FDA UDI
In Commercial Distribution
🇺🇸 United States
BioHermes Glycohemoglobin Quality Control (HPLC)
DI: 06935784430429
·
Model: BH-QC01
·
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 Quality Control (HPLC)
- Primary DI
- 06935784430429
- Version / Model
- BH-QC01
- Catalog Number
- HP-C122
- 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
- f74fc349-462e-4cce-9f11-e43bdaf49bfb
Device Description
The Glycohemoglobin Quality Control is intended to be used as an assayed quality control material to monitor the precision of testing procedures for glycohemoglobin analysis systems (the BH60 Automated Glycohemoglobin Analyzer and glycohemoglobin reagent kit) with the methodology of ion-exchange high-performance liquid chromatography (HPLC), manufactured by Wuxi BioHermes Bio & Medical Technology Co., Ltd.. Contents: 5 x Level 1 (1mL), 5 x Level 2 (1mL)
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 |
|---|---|---|---|---|
| 44435 | Glycated haemoglobin (HbA1c) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06935784430429 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius