Duns Number:528192913
Device Description: GluCoA1c Blood Glucose and Glycohemoglobin Analyzer.Intended use: GluCoA1c analyzer is for GluCoA1c Blood Glucose and Glycohemoglobin Analyzer.Intended use: GluCoA1c analyzer is for use with GluCoA1c Glycohemoglobin Test Kit and GluCoA1c Blood Glucose Test Strips to quantitatively measure the HbA1c in human capillary blood or venous blood,and the blood glucose in human capillary blood.
Catalog Number
GCA-M41
Brand Name
BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer
Version/Model Number
GLU-A1C M24
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
-
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
96f10d1b-8097-44d5-8e24-1163f15e4a0e
Public Version Date
September 05, 2022
Public Version Number
1
DI Record Publish Date
August 26, 2022
Package DI Number
16935784420267
Quantity per Package
18
Contains DI Package
06935784420260
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |