FDA UDI
In Commercial Distribution
🇺🇸 United States
BioHermes Glycohemoglobin Test Kit
DI: 06935784400071
·
Model: GLU-A1C S05
·
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
- 06935784400071
- Version / Model
- GLU-A1C S05
- Catalog Number
- GCA-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
- 2021-11-03
- Public Version Status
- Update
- Public Device Record Key
- d2bcc93c-7d64-4a5d-a2f2-e7544d863e8e
Device Description
Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 12 Tests/Kit . Intended use: This GluCoA1c glycohemoglobin test kit is intended to be used with the GluCoA1c blood glucose and glycohemoglobin analyzer to quantitatively measure glycohemoglobin (HbA1c) level in whole blood (capillary blood or venous blood). Contents: Code Chip x 1 piece; HbA1c Test Strip x 12 pieces; Sampler x 12 pieces; Buffer Ax 1 bottle; Buffer 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 | 06935784400071 | GS1 | ||||
| Package | 16935784400078 | GS1 | box | 8 | In Commercial Distribution | |
| Package | 26935784400075 | GS1 | box | 5 | In Commercial Distribution |