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BioHermes Glycohemoglobin Analytical Column
FDA UDIIdentity
- Trade Name
- BioHermes Glycohemoglobin Analytical Column FDA UDI
- Generic Name
- High performance liquid chromatography analyser column IVD FDA UDI
- Device Name
- Glycohemoglobin Analytical Column 1 pcs/kit (3000 tests) The Glycohemoglobin Analytical Column is intended to be used with the BH60 Automated Glycohemoglobin Analyzer, which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to separate glycohemoglobin (HbA1c) from human whole blood. FDA UDI
- Model / Reference
- BH-CC14 FDA UDI
- Description
- Glycohemoglobin Analytical Column 1 pcs/kit (3000 tests) The Glycohemoglobin Analytical Column is intended to be used with the BH60 Automated Glycohemoglobin Analyzer, which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to separate glycohemoglobin (HbA1c) from human whole blood. FDA UDI
Identifiers
- Catalog Number
- HP-Z114 FDA UDI
- Primary DI / UDI-DI
- 06935784430146 FDA UDI
- GMDN Term
- High performance liquid chromatography analyser column IVD 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: High performance liquid chromatography analyser column IVD
BioHermes Glycohemoglobin Analytical Column by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as High performance liquid chromatography analyser column IVD.
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- Precolumn Cartridge — Chromsystems Instruments & Chemicals GmbH · Class I
- HPLC Column — Chromsystems Instruments & Chemicals GmbH · Class I
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 fe9e4f5d-3704-476a-8454-22273df22549 34 fields · synced Jun 1, 2026