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What is IVDR?
The In Vitro Diagnostic Regulation (IVDR, EU 2017/746) is the new gold standard for diagnostic safety, performance and quality in Europe. In force since May 2022, IVDR raises the bar by requiring stronger clinical evidence, stricter risk classification, and enhanced traceability for every in vitro diagnostic (IVD) product.
From lab to patient - How does it affect me?
For manufacturers: IVDR demands, state of the art technology, robust clinical data, advanced quality systems, and closer oversight from Notified Bodies—driving innovation and ensuring only reliable, clinical significant, high-performance tests reach the market.
For buyers and laboratories: It offers peace of mind. Products are IVDR compliant, come with clear documentation, manufactured in certified quality facilities, trusted performance and improving service quality. IVDR has introduced a global database to give assurance that the device you are purchasing has been certified by a notified body.
For patients and clinicians: IVDR means greater confidence in every test result. With stricter post-market surveillance, lifecycle management and traceability, clinicians receive help from diagnostics that are not only innovative but also proven to be safe and effective.
| Certificate Number | Product Name | Catalogue Number | Classification | Classification Rule | EMDN Code | Grouping per CE Certificate |
|---|---|---|---|---|---|---|
| IVDR 803746 | HAEMOGLOBIN A1c II (HbA1c II) | HA4068 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3k | W0102060109 | Class C W0102 IVP 3007 |
| IVDR 803746 | HAEMOGLOBIN A1c II (HbA1c II) | HA8123 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3k | W0102060109 | Class C W0102 IVP 3007 |
| IVDR 803746 | HAEMOGLOBIN A1c II (HbA1c II) | HA8379 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3k | W0102060109 | Class C W0102 IVP 3007 |
| IVDR 803746 | BNP CONTROLS FOR BECKMAN (BNP CONTROL) | CQ10520 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3g | W0102152004 | Class C W0102 IVP 3007 |
| IVDR 803746 | BNP CONTROLS FOR ABBOTT (BNP CONTROL) | CQ10521 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3g | W0102152004 | Class C W0102 IVP 3007 |
| IVDR 803746 | Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array | EV4505 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W0102090199 | Class C W0102 IVP 3007 |
| IVDR 803746 | ConcizuTraceTM ELISA (CZM) | CZM10591 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01020899 | Class C W0102 IVP 3007 |
| IVDR 803746 | Pre-eclampsia Control Level 1 (Pre-eclampsia CONTROL 1) | PE10527 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Pre-eclampsia Control Level 2 (Pre-eclampsia CONTROL 2) | PE10528 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Pre-eclampsia Control Level 3 (Pre-eclampsia CONTROL 3) | PE10529 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Type 1 Diabetes (T1D) SNP Array | EV4489A/B | Class C (not self-test/near patient test/companion diagnostic) | Rule 3i | W010699 | Class C W0106 IVP 3011 |
| IVDR 803746 | SERUM BONE MARKER LEVEL 1 CONTROL (SERUM BONE MARKER CONTROL 1) | SBM10574 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152099 | Class B IVR 0608 |
| IVDR 803746 | SERUM BONE MARKER LEVEL 2 CONTROL (SERUM BONE MARKER CONTROL 2) | SBM10574 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152099 | Class B IVR 0608 |
| IVDR 803746 | SERUM BONE MARKER LEVEL 3 CONTROL (SERUM BONE MARKER CONTROL 3) | SBM10588 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152099 | Class B IVR 0608 |
| IVDR 803746 | Aldolase and Glutathione Reductase Calibrator (ALS & GLUT RED CAL) | AGR10571 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050301 | Class B IVR 0608 |
| IVDR 803746 | Aldolase and Glutathione Reductase Level 2 Control (ALS & GLUT RED CONTROL 2) | AGR10572 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050101 | Class B IVR 0608 |
| IVDR 803746 | Aldolase and Glutathione Reductase Level 3 Control (ALS & GLUT RED CONTROL 3) | AGR10589 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050101 | Class B IVR 0608 |
| IVDR 803746 | Evidence MultiSTAT Testosterone | EV4513 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102050110 | Class B IVR 0608 |
| IVDR 803746 | Evidence MultiSTAT Testosterone Control | EV4532 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152002 | Class B IVR 0608 |
| IVDR 803746 | Evidence MultiSTAT SHBG | EV4514 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102050109 | Class B IVR 0608 |
| IVDR 803746 | Evidence MultiSTAT SHBG Control | EV4533 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152002 | Class B IVR 0608 |
| IVDR 803746 | XANTHOCHROMIA NEGATIVE CONTROL (XANTHOCHROMIA Negative Control) | XN10502 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050102 | Class B IVR 0701 |
| IVDR 803746 | XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA Positive Control) | XN10505 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050102 | Class B IVR 0701 |
| IVDR 803746 | IMMUNOASSAY CONTROL - LEVEL 1 (IA CONTROL 1) | LIA5142 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050102 | Class B IVR 0701 |
| IVDR 803746 | IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2) | LIA5143 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050102 | Class B IVR 0701 |
| IVDR 803746 | IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3) | LIA5144 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050102 | Class B IVR 0701 |
| IVDR 803746 | Low Osmolality Control | UC10650 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050299 | Class B IVR 0701 |
| IVDR 803746 | Aldolase Calibration Serum (ALS CAL) | AD5000 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050302 | Class B IVR 0608 |
| IVDR 803746 | Aldolase Level 2 Control (ALS CONTROL 2) | AD5001 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050201 | Class B IVR 0608 |
| IVDR 803746 | Aldolase Level 3 Control (ALS CONTROL 3) | AD5002 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050201 | Class B IVR 0608 |
| IVDR 803746 | Apolipoprotein Calibrator 2 (APO CAL 2) | LP5047 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152203 | Class B IVR 0608 |
| IVDR 803746 | Apolipoprotein Calibrator (APO CAL) | LP3023 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152203 | Class B IVR 0608 |
| IVDR 803746 | Apolipoprotein Control - Level 2 (APO CONTROL 2) | LE5017 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152003 | Class B IVR 0608 |
| IVDR 803746 | Apolipoprotein Control - Level 1 (APO CONTROL 1) | LE5016 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152003 | Class B IVR 0608 |
| IVDR 803746 | Apolipoprotein Control - Level 3 (APO CONTROL 3) | LE5018 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152003 | Class B IVR 0608 |
| IVDR 803746 | CSF Control -Level 2 (CSF CONTROL 2) | CF1500 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050208 | Class B IVR 0608 |
| IVDR 803746 | CSF Control -Level 2 (CSF CONTROL 2) | CF1501 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050208 | Class B IVR 0608 |
| IVDR 803746 | Liquid CSF Control - Level 1 (CSF CONTROL 1) | CF10138 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050208 | Class B IVR 0608 |
| IVDR 803746 | Liquid CSF Control - Level 2 (CSF CONTROL 2) | CF10139 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050208 | Class B IVR 0608 |
| IVDR 803746 | Ammonia Ethanol Control - Level 1 (NH3/EtOH CONTROL 1) | EA1366 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050101 | Class B IVR 0608 |
| IVDR 803746 | Ammonia Ethanol Control - Level 2 (NH3/EtOH CONTROL 2) | EA1367 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050101 | Class B IVR 0608 |
| IVDR 803746 | Ammonia Ethanol Control - Level 3 (NH3/EtOH CONTROL 3) | EA1368 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050101 | Class B IVR 0608 |
| IVDR 803746 | Ethanol Calibrator and Control Set (EtOH CAL/CONTROL) | DA2703 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050101 | Class B IVR 0608 |
| IVDR 803746 | Haematology Control - Level 1,2,3 (HAEM CNTL - LEVEL 1,2,3) | HM5162 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0103010503 | Class B IVR 0608 |
| IVDR 803746 | Serum Low/High Calibrators (ISE CAL S) | IS2909 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101070399 | Class B IVR 0608 |
| IVDR 803746 | Urine Low/High Calibrators (ISE CAL U) | IS2910 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101070399 | Class B IVR 0608 |
| IVDR 803746 | Lipid Control - Level 1 (LPD CONTROL 1) | LE2661 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050202 | Class B IVR 0608 |
| IVDR 803746 | Lipid Control - Level 2 (LPD CONTROL 2) | LE2662 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050202 | Class B IVR 0608 |
| IVDR 803746 | Lipid Control - Level 3 (LPD CONTROL 3) | LE2663 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050202 | Class B IVR 0608 |
| IVDR 803746 | Lipid Control - Level 1 (LPD CONTROL 1) | LE2668 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050202 | Class B IVR 0608 |
| IVDR 803746 | Lipid Control - Level 3 (LPD CONTROL 3) | LE2670 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050202 | Class B IVR 0608 |
| IVDR 803746 | Lipoprotein (a) Calibrator Series (Lp(a) CAL SET) | LP3404 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152299 | Class B IVR 0608 |
| IVDR 803746 | Lipoprotein (a) Control (Lp (a) CONTROL 3) | LP3406 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152099 | Class B IVR 0608 |
| IVDR 803746 | Microalbumin Calibrator series (mALB CAL) | MA1567 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050302 | Class B IVR 0608 |
| IVDR 803746 | Parathyroid Hormone Control - Level 1 (PTH CONTROL 1) | PTH10110 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152002 | Class B IVR 0608 |
| IVDR 803746 | Parathyroid Hormone Control - Level 2 (PTH CONTROL 2) | PTH10111 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152002 | Class B IVR 0608 |
| IVDR 803746 | Parathyroid Hormone Control - Level 3 (PTH CONTROL 3) | PTH10112 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152002 | Class B IVR 0608 |
| IVDR 803746 | sLDL Control Level 1 (sLDL CONTROL 1) | LE5013 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050299 | Class B IVR 0608 |
| IVDR 803746 | sLDL Control Level 2 (sLDL CONTROL 2) | LE5014 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050299 | Class B IVR 0608 |
| IVDR 803746 | sLDL Control Level 3 (sLDL CONTROL 3) | LE5015 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050299 | Class B IVR 0608 |
| IVDR 803746 | sLDL Calibrator (sLDL CAL) | LE5015 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050299 | Class B IVR 0608 |
| IVDR 803746 | sLDL Calibrator (sLDL CAL) | CH5050 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050302 | Class B IVR 0608 |
| IVDR 803746 | Soluble Transferrin Receptor Controls (STFR CONTROL) | TF10162 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152006 | Class B IVR 0608 |
| IVDR 803746 | Soluble Transferrin Receptor Calibrator Series (STFR CAL) | TF10161 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152206 | Class B IVR 0608 |
| IVDR 803746 | Liquid Protein Calibrators (SP CAL (LIQ)) | IT2692 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152203 | Class B IVR 0608 |
| IVDR 803746 | Immunoglobulin Liquid Protein Calibrator (IG CAL) | IT3861 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152203 | Class B IVR 0608 |
| IVDR 803746 | Total Antioxidant Status Control | NX2331 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050299 | Class B IVR 0608 |
| IVDR 803746 | Active Vitamin B12 Control Level 1 (Active Vitamin B12 CONTROL 1) | VB10524 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152006 | Class B IVR 0608 |
| IVDR 803746 | Active Vitamin B12 Control Level 2 (Active Vitamin B12 CONTROL 2) | VB10525 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152006 | Class B IVR 0608 |
| IVDR 803746 | PARATHYROID HORMONE CONTROL - LEVEL 1 (PTH CONTROL 1) | PTH10608 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152002 | Class B IVR 0608 |
| IVDR 803746 | PARATHYROID HORMONE CONTROL - LEVEL 2 (PTH CONTROL 2) | PTH10609 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152002 | Class B IVR 0608 |
| IVDR 803746 | PARATHYROID HORMONE CONTROL - LEVEL 3 (PTH CONTROL 3) | PTH10610 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152002 | Class B IVR 0608 |
| IVDR 803746 | Direct HDL / LDL Cholestrol Calibrator (D LDL/HDL CAL) | CH2673 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050301 | Class B IVR 0608 |
| IVDR 803746 | Serum Indices | SI10448 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0101050102 | Class B IVR 0701 |
| IVDR 803746 | Cardiac Ultra Low Control (CRD CONTROL Ultra Low) | CQ10428 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152004 | Class B IVR 0701 |
| IVDR 803746 | Cardiac Control - Level 1 (CRD CONTROL 1) | CQ10429 | Class B (not self-test/near patient test/companion diagnostic) | Rule 6 | W0102152004 | Class B IVR 0701 |
| IVDR 803746 | Cardiac Control - Level 2 (CRD CONTROL 2) | CQ10430 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0102152004 | Class B IVR 0701 |
| IVDR 803746 | Cardiac Control - Level 3 (CRD CONTROL 3) | CQ10431 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0102152004 | Class B IVR 0701 |
| IVDR 803746 | Cardiac Control - Ultra Low (CRD CONTROL Ultra Low) | CQ10453 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0102152004 | Class B IVR 0701 |
| IVDR 803746 | Cardiac Control - Level 3 (CRD CONTROL 3) | CQ10456 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0102152004 | Class B IVR 0701 |
| IVDR 803746 | Liquid Chemistry Premium Plus - Level 1 (LIQ CHEM PREMIUM PLUS 1) | LUL5069 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050102 | Class B IVR 0701 |
| IVDR 803746 | Liquid Chemistry Premium Plus - Level 2 (LIQ CHEM PREMIUM PLUS 2) | LUN5070 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050102 | Class B IVR 0701 |
| IVDR 803746 | Liquid Chemistry Premium Plus - Level 3 (LIQ CHEM PREMIUM PLUS 3) | LUE5071 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050102 | Class B IVR 0701 |
| IVDR 803746 | Custom Liquid Chemistry Control Level 1 | LUL5167 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050102 | Class B IVR 0701 |
| IVDR 803746 | Custom Liquid Chemistry Control Level 2 | LUN5168 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050102 | Class B IVR 0701 |
| IVDR 803746 | Custom Liquid Chemistry Control Level 3 | LUE5169 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050102 | Class B IVR 0701 |
| IVDR 803746 | Serology Negative Control (SEROLOGY CONTROL -) | SR10351 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0105080807 | Class B IVR 0701 |
| IVDR 803746 | Serology I Positive Control SEROLOGY I CONTROL +) | SR10352 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0105080807 | Class B IVR 0701 |
| IVDR 803746 | Serology II Positive Control (SEROLOGY II CONTROL +) | SR10353 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0105080807 | Class B IVR 0701 |
| IVDR 803746 | Serology III Positive Control (SEROLOGY III CONTROL +) | SR10354 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0105080807 | Class B IVR 0701 |
| IVDR 803746 | Serology ToRCH Negative Control (ToRCH CONTROL -) | SR10347 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0105080807 | Class B IVR 0701 |
| IVDR 803746 | Serology ToRCH Negative Control (ToRCH CONTROL -) | SR10348 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0105080807 | Class B IVR 0701 |
| IVDR 803746 | Serology ToRCH IgM Positive Control (ToRCH IgM Control +) | SR10349 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0105080807 | Class B IVR 0701 |
| IVDR 803746 | Serology ToRCH EBV Positive Control (ToRCH EBV Control +) | SR10350 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0105080807 | Class B IVR 0701 |
| IVDR 803746 | Serology Lyme Disease Negatve Control (LYME CONTROL -) | SR10345 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0105080807 | Class B IVR 0701 |
| IVDR 803746 | Serology Lyme Disease Positive Control (LYME CONTROL +) | SR10346 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0105080807 | Class B IVR 0701 |
| IVDR 803746 | Human Precision Control -Level 2 (HUM PREC CONTROL 2) | UN1557 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0105080807 | Class B IVR 0701 |
| IVDR 803746 | Human Precision Control -Level 3 (HUM PREC CONTROL 3) | UE1558 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0105080807 | Class B IVR 0701 |
| IVDR 803746 | Serology HBeAg Positive Control (HBeAg CONTROL +) | SR10459 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0105080899 | Class B IVR 0701 |
| IVDR 803746 | Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3) | BR10391 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050203 | Class B IVR 0701 |
| IVDR 803746 | Custom Liquid Therapeutic Drug Control Level 1 | HD3145 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0102152001 | Class B IVR 0701 |
| IVDR 803746 | Custom Liquid Therapeutic Drug Control Level 2 | HD3146 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0102152001 | Class B IVR 0701 |
| IVDR 803746 | Custom Liquid Therapeutic Drug Control Level 3 | HD3147 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0102152001 | Class B IVR 0701 |
| IVDR 803746 | Custom Liquid Immunoassay Control Level 1 | LIA3148 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W01021521 | Class B IVR 0701 |
| IVDR 803746 | Custom Liquid Immunoassay Control Level 2 | LIA3149 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W01021521 | Class B IVR 0701 |
| IVDR 803746 | Custom Liquid Immunoassay Control Level 3 | LIA3150 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W01021521 | Class B IVR 0701 |
| IVDR 803746 | Custom Liquid Specific Protein Control Level 1 | PS3151 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0102152003 | Class B IVR 0701 |
| IVDR 803746 | Custom Liquid Specific Protein Control Level 2 | PS3152 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0102152003 | Class B IVR 0701 |
| IVDR 803746 | Custom Liquid Urine Control Level 1 | UC5170 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050207 | Class B IVR 0701 |
| IVDR 803746 | Custom Liquid Urine Control Level 2 | UC5171 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0101050207 | Class B IVR 0701 |
| IVDR 803746 | Troponin T Control | CQ10462 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W0102152004 | Class B IVR 0701 |
| IVDR 803746 | Tropinin T Control | CQ10450 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W0102152004 | Class C W0102 IVP 3007 |
| IVDR 803746 | Tumour Marker Control - Level 2 (TMR CONTROL 2) | TU5002 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3h | W0102152005 | Class C W0102 IVP 3007 |
| IVDR 803746 | Tumour Marker Control - Level 3 (TMR CONTROL 3) | TU5003 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3h | W0102152005 | Class C W0102 IVP 3007 |
| IVDR 803746 | AMH CONTROL LEVEL 1 (AMH CONTROL 1) | AMH10509 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3h | W0102152008 | Class C W0102 IVP 3007 |
| IVDR 803746 | AMH CONTROL LEVEL 2 (AMH CONTROL 2) | AMH10514 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3h | W0102152008 | Class C W0102 IVP 3007 |
| IVDR 803746 | AMH CONTROL LEVEL 3 (AMH CONTROL 3) | AMH10515 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3h | W0102152008 | Class C W0102 IVP 3007 |
| IVDR 803746 | AMH CONTROL LEVEL 4 (AMH CONTROL 4) | AMH10516 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3h | W0102152008 | Class C W0102 IVP 3007 |
| IVDR 803746 | B2 Microglobulin calibrator (B2M CAL) | BM10444 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3h | W0102152208 | Class C W0102 IVP 3007 |
| IVDR 803746 | Cystatin C Control - Level 2 (CYSC CONTROL 2) | CYS10446 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W0102152003 | Class C W0102 IVP 3007 |
| IVDR 803746 | Cystatin C Control - Level 3 (CYSC CONTROL 3) | CYS10447 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W0102152003 | Class C W0102 IVP 3007 |
| IVDR 803746 | Cystatin C Calibrator (CYSC CAL) | CYS10445 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W0102152208 | Class C W0102 IVP 3007 |
| IVDR 803746 | HbA1c II Calibrator Set (HbA1c II CAL) | HA8124 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W0102152203 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Speciality Control I - Level 1 (IA SPECIALITY I LEV 1) | IAS3113 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Speciality Control I - Level 2 (IA SPECIALITY I LEV 2) | IAS3114 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Speciality Control I - Level 3 (IA SPECIALITY I LEV 3) | IAS3115 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Speciality Control II - Level 1 (IA Speciality II Lev 1) | IAS3117 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Speciality Control II - Level 2 (IA Speciality II Lev 2) | IAS3118 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Speciality Control II - Level 3 (IA Speciality II Lev 3) | IAS3119 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Premium -Tri-Level (IA Premium 1, 2, 3) | IA2633 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Premium -Level 1 (IA Premium 1) | IA2638 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Premium -Level 2 (IA Premium 2) | IA2639 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Premium -Level 2 (IA Premium 2) | IA2640 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Premium Plus - Level 1 (IA Premium Plus 1) | IA3109 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Premium Plus - Level 2 (IA Premium Plus 2) | IA3110 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Premium Plus - Level 2 (IA Premium Plus 2) | IA3111 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Immunoassay Premium Plus - Tri-Level (IA Premium Plus Tri-Level) | IA3112 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Maternal Control - Level 1 (MATERNAL CONTROL 1) | MSS5024 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3l | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Maternal Control - Level 2 (MATERNAL CONTROL 2) | MSS5025 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3l | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Maternal Control - Level 3 (MATERNAL CONTROL 3) | MSS5026 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3l | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Liquid Immunoassay Control | LIA10568 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Liquid Immunoassay Control | LIA10569 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Liquid Immunoassay Control | LIA10570 | Class C (not self-test/near patient test/companion diagnostic) | Rule 3j | W01021521 | Class C W0102 IVP 3007 |
| IVDR 803746 | Cardiac Control - Level 1 (CRD CONTROL 1) | W0102152004 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W01021521 | Class B IVR 0701 |
| IVDR 803746 | Cardiac Control - Level 2 (CRD CONTROL 2) | CQ10455 | Class B (not self-test/near patient test/companion diagnostic) | Rule 7 | W01021521 | Class B IVR 0701 |