Identity
- Trade Name
- Glycated Hemoglobin (HbA1C) Analyzer IVD FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1C) analyser IVD FDA UDI
- Device Name
- Glycated hemoglobin (HbA1C) analyzer IVD, 90 Sample Loader, Remanufactured FDA UDI
- Model / Reference
- G8-90SLR FDA UDI
- Description
- Glycated hemoglobin (HbA1C) analyzer IVD, 90 Sample Loader, Remanufactured FDA UDI
Identifiers
- Catalog Number
- 021561R FDA UDI
- Primary DI / UDI-DI
- 00853931008016 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1C) analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 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
Glycated Hemoglobin (HbA1C) Analyzer IVD by Tosoh Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Tosoh Bioscience, Inc.
Sources (1)
- FDA UDI f936d9c2-06a1-4bda-8fa3-e61755ddeba9 35 fields · synced Jun 8, 2026