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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) 25 Tests/Kit. lntended use: This A1C EZ2.0 Glyconemogoin Test Kit is intended to be used with the A1CEZ 2.0Glyconemogloin Arnalyzer to quaniativly measue hemoglobinA1c(HbA1c) level in whole blood (capilary blood).This test ki i for self-testinguse, as an aid to monitor the effectiveness of diabetes control. Contents: Code Chip x 1 piece; HbA1c Test Strip x 25 pieces; Sampler x 25 pieces;Buffer Ax 1 bottle;Bulffer Bx 1 bottle. FDA UDI
- Model / Reference
- A1C EZ 2.0 FDA UDI
- Description
- Glycohemoglobin Test Kit ( Boronate Affinity Chromatography) 25 Tests/Kit. lntended use: This A1C EZ2.0 Glyconemogoin Test Kit is intended to be used with the A1CEZ 2.0Glyconemogloin Arnalyzer to quaniativly measue hemoglobinA1c(HbA1c) level in whole blood (capilary blood).This test ki i for self-testinguse, as an aid to monitor the effectiveness of diabetes control. Contents: Code Chip x 1 piece; HbA1c Test Strip x 25 pieces; Sampler x 25 pieces;Buffer Ax 1 bottle;Bulffer Bx 1 bottle. FDA UDI
Identifiers
- Catalog Number
- A1C-S22 FDA UDI
- Primary DI / UDI-DI
- 06935784400033 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 5dff699b-7ff3-4117-a851-1fd50d787cb3 34 fields · synced Jun 8, 2026