FDA UDI
In Commercial Distribution
🇺🇸 United States
BioHermes Glycohemoglobin Test Kit
DI: 06935784400033
·
Model: A1C EZ 2.0
·
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
Product Codes
0
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BioHermes Glycohemoglobin Test Kit
- Primary DI
- 06935784400033
- Version / Model
- A1C EZ 2.0
- Catalog Number
- A1C-S22
- 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
- 2021-11-03
- Public Version Status
- Update
- Public Device Record Key
- 5dff699b-7ff3-4117-a851-1fd50d787cb3
Device Description
Glycohemoglobin Test Kit ( Boronate Affinity Chromatography) 25 Tests/Kit. lntended use: This A1C EZ2.0 Glyconemogoin Test Kit is intended to be used with the A1CEZ 2.0Glyconemogloin Arnalyzer to quaniativly measue hemoglobinA1c(HbA1c) level in whole blood (capilary blood).This test ki i for self-testinguse, as an aid to monitor the effectiveness of diabetes control. Contents: Code Chip x 1 piece; HbA1c Test Strip x 25 pieces; Sampler x 25 pieces;Buffer Ax 1 bottle;Bulffer Bx 1 bottle.
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 | 06935784400033 | GS1 | ||||
| Package | 16935784400030 | GS1 | box | 8 | In Commercial Distribution | |
| Package | 26935784400037 | GS1 | box | 5 | In Commercial Distribution |