Identity
- Trade Name
- D-10 FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1C) analyser IVD FDA UDI
- Model / Reference
- 2200600 FDA UDI
Identifiers
- Catalog Number
- 2200600 FDA UDI
- Primary DI / UDI-DI
- 00847817006098 FDA UDI
- FDA Product Code
- LDM FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1C) analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glycated haemoglobin (HbA1C) analyser IVD
D-10 by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1C) analyser IVD.
- Glycated Hemoglobin (HbA1C) Analyzer IVD — TOSOH BIOSCIENCE, INC. · Class II
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- Trinity Biotech — Primus Corp. · Class II
- ADAMS™ A1c HA-8180V (UL) Analyzer — ARKRAY USA, INC. · Class II
- URIGHT Hemoglobin A1c Analyzer — TAIDOC TECHNOLOGY CORPORATION · Class I
- Trinity Biotech — Primus Corp. · Class II
- BioHermes Automated Glycohemoglobin Analyzer — Wuxi Biohermes Bio & Medical Technology Co., Ltd. · Class II
- DCA Vantage® Analyzer — Siemens Healthcare Diagnostics · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 7bb85b2e-9e58-4584-ace8-f3d5c29535ff 36 fields · synced May 30, 2026