Duns Number:528192913
Device Description: Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 12 Tests/Kit.Intended use: T 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.
Catalog Number
GCA-S22
Brand Name
BioHermes Glycohemoglobin Test Kit
Version/Model Number
GLU-A1C S03
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
45a11a20-5d99-4d88-bb70-c9e5b84ebe44
Public Version Date
November 03, 2021
Public Version Number
2
DI Record Publish Date
May 25, 2021
Package DI Number
16935784400047
Quantity per Package
8
Contains DI Package
06935784400040
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 |