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BioHermes Glycohemoglobin Test Kit
FDA UDIIdentity
- Trade Name
- BioHermes Glycohemoglobin Test Kit FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
- Device Name
- Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 12 Tests/Kit. Intended use: This GluCoA1c glycohemoglobin test kit is intended to be used with the GluCoA1c blood glucose and glycohemoglobin analyzer to quantitatively measure glycohemoglobin (HbA1c) level in whole blood (capillary blood or venous blood). Contents: Code Chip x 1 piece; HbA1c Test Strip x 12 pieces; Sampler x 12 pieces; Buffer Ax 1 bottle; Buffer Bx 1 bottle. FDA UDI
- Model / Reference
- GLU-A1C S03 FDA UDI
- Description
- Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 12 Tests/Kit. Intended use: This GluCoA1c glycohemoglobin test kit is intended to be used with the GluCoA1c blood glucose and glycohemoglobin analyzer to quantitatively measure glycohemoglobin (HbA1c) level in whole blood (capillary blood or venous blood). Contents: Code Chip x 1 piece; HbA1c Test Strip x 12 pieces; Sampler x 12 pieces; Buffer Ax 1 bottle; Buffer Bx 1 bottle. FDA UDI
Identifiers
- Catalog Number
- GCA-S22 FDA UDI
- Primary DI / UDI-DI
- 06935784400040 FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
BioHermes Glycohemoglobin Test Kit by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Sources (1)
- FDA UDI 45a11a20-5d99-4d88-bb70-c9e5b84ebe44 34 fields · synced Jun 1, 2026