FDA UDI
In Commercial Distribution
🇺🇸 United States
BioHermes A1cChek Pro Glycohemoglobin Test Kit
DI: 06935784400064
·
Model: A1C-PRO S01
·
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
Product Codes
0
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BioHermes A1cChek Pro Glycohemoglobin Test Kit
- Primary DI
- 06935784400064
- Version / Model
- A1C-PRO S01
- Catalog Number
- A1C-S32
- 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
- 2021-07-19
- Public Version Status
- Update
- Public Device Record Key
- 4d3ff21c-13f1-4571-80e5-a4af14598c8d
Device Description
A1cChek Pro Glycohemoglobin Test Kit (Boronate Affinity Chromatography), 100 Tests/Kit. Intended use: This A1cChek Pro Glycohemoglobin Test Kit is intended to be used with the A1cChek Pro Glycohemoglobin Analyzer to quantitatively measure hemoglobin A1c(HbA1c) level in whole blood (capillary blood or venous blood).This test kit is for professional use. Contents: Code Chip x 1 piece; HbA1c Test Strip x 100 pieces; Sampler x 100 pieces; Buffer Ax 1 bottle; Buffer Bx 1 bottle; Blood Collector x 100 pieces.
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 53313 | Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen using a liquid chromatography method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06935784400064 | GS1 | ||||
| Package | 16935784400061 | GS1 | box | 2 | In Commercial Distribution | |
| Package | 26935784400068 | GS1 | box | 5 | In Commercial Distribution |