Identity
- Trade Name
- BioHermes Glycohemoglobin Test Kit FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
- Device Name
- GluCoA1c Glycohemoglobin Test Kit EUDAMEDGlycohemoglobin 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 S05 EUDAMEDFDA UDIGCA-S32 EUDAMED
- 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-S32 FDA UDI
- Primary DI / UDI-DI
- 06935784400071 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06935784400071 EUDAMED
- EMDN Code
- W0101060107 HBA1C TEST STRIPS EUDAMED
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
Yes
Near-Patient Testing
Yes
Professional Testing
No
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
BioHermes Glycohemoglobin Test Kit by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | N/A | Unknown |
| 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 (2)
- FDA UDI d2bcc93c-7d64-4a5d-a2f2-e7544d863e8e 34 fields · synced Jun 19, 2026
- EUDAMED a31f92a0-c7b8-4424-945e-1d589c672be3 61 fields · synced Jun 19, 2026