FDA UDI
In Commercial Distribution
🇺🇸 United States
BH60 Glycohemoglobin Reorder Pack (HPLC, Variant Mode)
DI: 06935784430740
·
Model: BH-P02
·
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BH60 Glycohemoglobin Reorder Pack (HPLC, Variant Mode)
- Primary DI
- 06935784430740
- Version / Model
- BH-P02
- Catalog Number
- HP-P224
- 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
- 05446550-0013-4d1e-aa99-4d2aa26408b8
Device Description
BH60 Glycohemoglobin Reorder Pack (HPLC, Variant Mode) 3000 tests/box BH60 Glycohemoglobin Reorder Pack (HPLC, Variant Mode) is intended to be used with the BH60 Automated Glycohemoglobin Analyzer manufactured by Wuxi Biohermes Bio & Medical Technology Co., Ltd., which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to quantitatively measure hemoglobin A1c (HbA1c) level in whole blood. Contents:Elution Buffer A 6×1800mL, Elution Buffer B 3×1800mL, Hemolysis & Wash Buffer H 12×2000 mL, Column 1x 3000 tests.
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
- 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 | 06935784430740 | GS1 |