Duns Number:528192913
Device Description: Glycohemoglobin Test Kit ( Boronate Affinity Chromatography) 25 Tests/Kit.lntended use: T Glycohemoglobin Test Kit ( Boronate Affinity Chromatography) 25 Tests/Kit.lntended use: This A1C EZ2.0 Glyconemogoin Test Kit is intended to be used with the A1CEZ 2.0Glyconemogloin Arnalyzer to quaniativly measue hemoglobinA1c(HbA1c) level in whole blood (capilary blood).This test ki i for self-testinguse, as an aid to monitor the effectiveness of diabetes control.Contents: Code Chip x 1 piece; HbA1c Test Strip x 25 pieces; Sampler x 25 pieces;Buffer Ax 1 bottle;Bulffer Bx 1 bottle.
Catalog Number
A1C-S22
Brand Name
BioHermes Glycohemoglobin Test Kit
Version/Model Number
A1C EZ 2.0
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
5dff699b-7ff3-4117-a851-1fd50d787cb3
Public Version Date
November 03, 2021
Public Version Number
2
DI Record Publish Date
May 25, 2021
Package DI Number
16935784400030
Quantity per Package
8
Contains DI Package
06935784400033
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 |