FDA UDI
In Commercial Distribution
🇺🇸 United States
BioHermes A1cChek Express Glycohemoglobin Analyzer
DI: 06935784411077
·
Model: A1C-EXP M12
·
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BioHermes A1cChek Express Glycohemoglobin Analyzer
- Primary DI
- 06935784411077
- Version / Model
- A1C-EXP M12
- Catalog Number
- A1C-M41
- 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
- 2021-05-25
- Public Version
- 2
- Public Version Date
- 2021-11-02
- Public Version Status
- Update
- Public Device Record Key
- 999d3f3f-47d4-4405-9e1f-c9ede29d5718
Device Description
A1cChek Express Glycohemoglobin analyzer is for use with the A1cChek Express Glycohemoglobin Test Kit to quantitatively measure the HbA1c in human capillary blood or venous 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 |
|---|---|---|---|---|
| 62206 | Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care | A collection of devices including a portable, electrically-powered, semi-automated or automated instrument (meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06935784411077 | GS1 | ||||
| Package | 16935784411074 | GS1 | box | 4 | In Commercial Distribution |