Identity
- Trade Name
- CAPI 3 Hb A1c EUDAMEDFDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
- Device Name
- CAPI 3 Hb A1c EUDAMEDDevice intended for measurement of HbA1c in whole blood using capillary electrophoresis FDA UDI
- Model / Reference
- 2515 EUDAMEDFDA UDI
- Description
- Device intended for measurement of HbA1c in whole blood using capillary electrophoresis FDA UDI
Identifiers
- Catalog Number
- 2515 FDA UDI
- Primary DI / UDI-DI
- 03607360025154 EUDAMEDFDA UDI
- Basic UDI-DI
- 3607362515BUCZ EUDAMED
- FDA Product Code
- JJX FDA UDILCP FDA UDIPDJ FDA UDI
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI864.7470 FDA UDI862.1373 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
CAPI 3 Hb A1c by Sebia — Class C — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171537 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 3607362515BUCZ | Class C | Active |
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Manufacturer
- Manufacturer
- sebia
- EUDAMED SRN
- FR-MF-000003520
Sources (3)
- EUDAMED 4f6152ce-d208-403f-8e84-ebd0a10fb3ad 61 fields · synced Jul 27, 2026
- FDA UDI 027f8a45-b336-4981-a888-2253da489e0a 35 fields · synced May 30, 2026
- FDA 510(k) K171537 1 fields · synced May 18, 2026