Duns Number:528192913
Device Description: A1cChek Pro Glycohemoglobin Test Kit (Boronate Affinity Chromatography), 100 Tests/Kit. I A1cChek Pro Glycohemoglobin Test Kit (Boronate Affinity Chromatography), 100 Tests/Kit. Intended use: This A1cChek Pro Glycohemoglobin Test Kit is intended to be used with the A1cChek Pro Glycohemoglobin Analyzer to quantitatively measure hemoglobin A1c(HbA1c) level in whole blood (capillary blood or venous blood).This test kit is for professional use. Contents: Code Chip x 1 piece; HbA1c Test Strip x 100 pieces; Sampler x 100 pieces; Buffer Ax 1 bottle; Buffer Bx 1 bottle; Blood Collector x 100 pieces.
Catalog Number
A1C-S32
Brand Name
BioHermes A1cChek Pro Glycohemoglobin Test Kit
Version/Model Number
A1C-PRO S01
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
4d3ff21c-13f1-4571-80e5-a4af14598c8d
Public Version Date
July 19, 2021
Public Version Number
2
DI Record Publish Date
May 25, 2021
Package DI Number
16935784400061
Quantity per Package
2
Contains DI Package
06935784400064
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 |