FDA UDI
In Commercial Distribution
🇺🇸 United States
BioHermes Glycohemoglobin Analytical Column
DI: 06935784430122
·
Model: BH-CC12
·
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioHermes Glycohemoglobin Analytical Column
- Primary DI
- 06935784430122
- Version / Model
- BH-CC12
- Catalog Number
- HP-Z112
- Company Name
- Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
- Labeler DUNS
- 528192913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-05
- Public Version
- 1
- Public Version Date
- 2022-01-13
- Public Version Status
- New
- Public Device Record Key
- a6214a9c-672f-46e4-b4ae-7635d50775f5
Device Description
Glycohemoglobin Analytical Column 1 pcs/kit (1000 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44407 | High performance liquid chromatography analyser column IVD | A component of a high performance liquid chromatograph (HPLC) analyser that functions as a narrow flow-through tube through which different chemical constituents of a sample pass in a high pressure liquid stream at different rates, depending on their various chemical and physical properties and their interaction with a specific column filling. The internal diameter of the HPLC tubing (typically ranges from under 0.3 mm to greater than 10 mm) determines the quantity of analyte that can be loaded and analyser sensitivity. The tubes are made of various materials including stainless steel and fused silica. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06935784430122 | GS1 |