Duns Number:528192913
Device Description: A1cChek Pro Glycohemoglobin Analysis System is intended for the percent determination of H A1cChek Pro Glycohemoglobin Analysis System is intended for the percent determination of Hemoglobin A1c in human whole blood using boronate affinity chromatography. A1cChek Pro Glycohemoglobin Analyzer is intended for Professional Use Only. For In Vitro Diagnostic Use Only.
Catalog Number
A1C-M31
Brand Name
BioHermes A1cChek Pro Glycohemoglobin Analyzer
Version/Model Number
A1C EZ Auto 4 W
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"
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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
213076e3-fa8b-43a4-822d-4bed37d85b9f
Public Version Date
June 02, 2021
Public Version Number
1
DI Record Publish Date
May 25, 2021
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 |