Duns Number:528192913
Device Description: The Glycohemoglobin Quality Control is intended to be used as an assayed quality control m 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)
Catalog Number
HP-C122
Brand Name
BioHermes Glycohemoglobin Quality Control (HPLC)
Version/Model Number
BH-QC01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
f74fc349-462e-4cce-9f11-e43bdaf49bfb
Public Version Date
January 13, 2022
Public Version Number
1
DI Record Publish Date
January 05, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |