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BioHermes Glycohemoglobin Reagent Kit (HPLC, Variant Mode)
FDA UDIIdentity
- Trade Name
- BioHermes Glycohemoglobin Reagent Kit (HPLC, Variant Mode) FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
- Device Name
- Glycohemoglobin Reagent kit (HPLC, Variant Mode) 2000 tests/box The glycohemoglobin reagent kit (HPLC) is intended to be used with the BH60 Automated Glycohemoglobin Analyzer manufactured by Wuxi Biohermes Bio & Medical Technology Co., Ltd., which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to quantitatively measure hemoglobin A1c (HbA1c) level in whole blood. Contents:Elution Buffer A 4×1800mL, Elution Buffer B 2×1800mL, Hemolysis & Wash Buffer H 8×2000mL FDA UDI
- Model / Reference
- BH-L02 FDA UDI
- Description
- Glycohemoglobin Reagent kit (HPLC, Variant Mode) 2000 tests/box The glycohemoglobin reagent kit (HPLC) is intended to be used with the BH60 Automated Glycohemoglobin Analyzer manufactured by Wuxi Biohermes Bio & Medical Technology Co., Ltd., which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to quantitatively measure hemoglobin A1c (HbA1c) level in whole blood. Contents:Elution Buffer A 4×1800mL, Elution Buffer B 2×1800mL, Hemolysis & Wash Buffer H 8×2000mL FDA UDI
Identifiers
- Catalog Number
- HP-L223 FDA UDI
- Primary DI / UDI-DI
- 06935784430337 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
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
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 Reagent Kit (HPLC, Variant Mode) by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — FDA UDI — listed in FDA GUDID
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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 c71fb32f-91d4-402b-b9ed-9f35d088c425 34 fields · synced Jun 8, 2026