IVD instrumentsChemistry / immunochemistry instruments
Chemistry / immunochemistry rapid tests + POC tests
EMDN code W020106
Manufacturers registered in Europe (EUDAMED) 72
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 74
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Bio-Rad Present in Europe in other categories | United States | VARIANT II TURBO D-10 VARIANT II Hemoglobin A1c D-100 VARIANT II TURBO Link Hemoglobin Capillary Collection System (HCCS) | K161687 (2016) |
| Primus Corp. | United States | Trinity Biotech | K062658 (2007) |
| Circassia AB | United States | NIOX | K170983 (2017) |
| HORIBA INSTRUMENTS INCORPORATED | United States | Pointe Scientific, Inc. HbA1c Fructosamine Pointe Scientific, Inc. Glyco Standard POINTE SCIENTIFIC Fructosamine Pointe Scientific, Inc. Gyco Lyse | registered |
| DREW SCIENTIFIC, INC. | United Kingdom | Drew Scientific JAS Diagnostics Drew | K933287 (1993) |
| CAROLINA LIQUID CHEMISTRIES CORPORATION | United States | CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c CTL SET PART# 7-H7541-CTL CAROLINA LIQUID CHEMISTRIES CORP.® FRUC CONTROL SET CC030 CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 HbA1c RGT KIT Pt No. ST300 CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300 CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c CAL SET PART# 7-H7541-CAL CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c REAGENT CC300 | registered |
| STANBIO LABORATORY, L.P. | United States | Direct Glycohemoglobin (HbA1c) Glycohemoglobin Bi-Level Controls Sirrus® Direct Gylcohemoglobin (HbA1c) Direct Glycohemoglobin (HbA1c) Control Set Glycohemoglobin Direct Glycohemoglobin (HbA1c) Calibrator Set | registered |
| Beckman Coulter, Inc. Present in Europe in other categories | United States | AU Synchron | K182651 (2019) |
| Caire Diagnostics Inc. Present in Europe in other categories | United States | CAIRE Diagnostics | K213611 (2023) |
| Randox Laboratories, Ltd. Present in Europe in other categories | United Kingdom | HbA1C FRUC FRUCTOSAMINE (FRUC) HAEMOGLOBIN A1c (HbA1c) HbA1C CAL | K023763 (2003) |
| Bosch Healthcare Solutions GmbH Present in Europe in other categories | Germany | Vivatmo pro Oxycap Vivatmo pro Level 0 Spare part: Vivatmo pro handheld US Vivatmo pro Spare part: Vivatmo pro base station US | K243926 (2025) |
| POLYMER TECHNOLOGY SYSTEMS, INC. | United States | A1CNow® Self Check Test System A1CNow®+ Multi-Use Test System (10 count) A1CNow®+ Multi-UseTest System (20 count) TRUE+ A1CNow Self Check A1CNow Self Check, 8ct. | registered |
| Sebia Present in Europe in other categories | United States | MINICAP Hb A1c CAPI 3 Hb A1c CAPILLARYS Hb A1c | K171861 (2018) |
| ASAHI KASEI PHARMA CORPORATION | Japan | Lucica® Glycated Albumin-L GA R-2 Lucica® Glycated Albumin-L ALB R-1 Lucica® Glycated Albumin-L GA R-1 Lucica® Glycated Albumin-L ALB R-2 | K170147 (2017) |
| KPI HEALTHCARE, INC. | – | CURO A1c Curo A1c Analyzer | registered |
| Kamiya Biomedical Co. Present in Europe in other categories | United States | K-ASSAY® Hemoglobin A1c Reagent K-ASSAY® Hemoglobin A1c Reagent (L) K-ASSAY® Hemoglobin A1c Control K-ASSAY® Hemoglobin A1c Calibrator | registered |
| Bedfont Scientific, Ltd. Present in Europe in other categories | United Kingdom | NObreath® FeNOBreath NOBreath | K203695 (2021) |
| CLINICAL DIAGNOSTIC SOLUTIONS, INC. Present in Europe in other categories | United States | HbA1c Reagent Set HbA1c Calibrator Set HbA1c Control Set | registered |
| Diazyme Laboratories Present in Europe in other categories | United States | Diazyme | K160762 (2016) |
| ELITECHGROUP INC. Present in Europe in other categories | United States | Direct A1c Control Kit Direct A1c Reagent Kit Direct A1c Calibrator Kit | registered |
| Tosoh Bioscience, Inc. | United States | Glycated Hemoglobin (HbA1C) Analyzer IVD Tosoh Automated Glycohemoglobin Analyzer HLC-723G8R Glycated Hemoglobin (HbA1C) Analyser IVD, 290 Loader, Remanufactured | K250073 (2025) |
| ALFA WASSERMANN, INC. | United States | ACE | K063306 (2007) |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| Medical Graphics Corp. Present in Europe in other categories | United States | Fenom Flo™ | registered |
| Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories | United States | VITROS | K142595 (2015) |
| Qurasense, Inc. | United States | Qvin | K231465 (2023) |
| TECO DIAGNOSTICS | United States | Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent Set Teco Diagnostics Hemoglobin A1c Set for TC Matrix Systems | K051200 (2005) |
| WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | – | CVS Health At Home A1C Test Kit | registered |
| CLEARCHEM DIAGNOSTICS INC. | – | ClearChem Diagnostics Inc. Hemoglobin A-1c | registered |
| Cliniqa Corporation | United States | Hemoglobin A1C Reagent | registered |
| Drawbridge Health, Inc. | United States | OneDraw A1C Test System | K183230 (2019) |
| HOPKINS UNIFORM COMPANY | – | Hopkins Medical Products® | registered |
| Medica Corp. | United States | HbA1c Reagent Kit | K120497 (2012) |
| Siemens Healthcare Diagnostics Products GmbH Present in Europe in other categories | Germany | IMMULITE® Systems COR Calibration Verification Material Cortisol | registered |
| WAL-MART STORES, INC. | – | ReliOn™ 2CT A1C Meter | registered |
| WALGREEN CO. | – | Well at Walgreens | registered |
| Abbott Rapid Diagnostics | United States | – | K171650 (2017) |
| Alere Technologies AS | Norway | – | K182988 (2018) |
| Alfa Wassermann Diagnostic Technologies, Inc. | United States | – | K170623 (2018) |
| Bio-Rad Laboratories (Bio-Rad Services France) Present in Europe in other categories | France | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Ekf-Diagnostic GmbH Present in Europe in other categories | Germany | – | K180509 (2019) |
| Emsere, Inc | Netherlands | – | registered |
| HITACHI HIGH-TECH CORP. Present in Europe in other categories | Japan | – | registered |
| HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical | United States | – | registered |
| High Technology, Inc. Present in Europe in other categories | United States | – | registered |
| Inpeco SA Present in Europe in other categories | Italy | – | registered |
| Ixensor Co, Ltd. | Taiwan | – | K192369 (2019) |
| Jana Care, Inc. | United States | – | K192987 (2020) |
| KAINOS LABORATORIES INC | Japan | – | registered |
| LRE MEDICAL GMBH | Germany | – | registered |
| Medi Soft SA | Belgium | – | registered |
| Mgc Diagnostics Corporation | United States | – | K251674 (2025) |
| Nagase Diagnostics Co., Ltd. | Japan | – | registered |
| Neelyx Labs, Inc | United States | – | registered |
| Nova Biomedical Corp. | United States | – | K221326 (2024) |
| OEM SYSTEMS CO. LTD. | Japan | – | registered |
| PWNHealth Chicago, LLC | United States | – | registered |
| QuidelOrtho Corporation | United States | – | registered |
| Roche Diagnostics Operations (Rdo) | United States | – | K193053 (2020) |
| Roche Diagnostics Operations Inc. | United States | – | K163633 (2017) |
| SEKISUI MEDICAL CO., LTD. | Japan | – | registered |
| Sanner GmbH | Germany | – | registered |
| Sekisui Diagnostics P.E.I., Inc. | Canada | – | K173206 (2018) |
| Sekisui Diagnostics, LLC Present in Europe in other categories | United States | – | registered |
| Shanghai Medconn Biotechnology Co., Ltd. Present in Europe in other categories | China | – | registered |
| Shanghai Medconn Medical Technology Co., Ltd. Present in Europe in other categories | China | – | K252749 (2026) |
| Shenzhen Lifotronic Technology Co., Ltd. Present in Europe in other categories | China | – | K260468 (2026) |
| Shijiazhuang Hipro Biotechnology Co., Ltd. Present in Europe in other categories | China | – | K220999 (2024) |
| Skyla Corporation H.S.P.B | Taiwan | – | K173127 (2018) |
| Spirosure, Inc. | United States | – | K182874 (2019) |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | registered |
| Trinity Biotech USA Present in Europe in other categories | United States | – | registered |
| VitalScientific B.V. Present in Europe in other categories | United States | – | registered |
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