Duns Number:528192913
Device Description: A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin con A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentration as anaid to monitor the risk of developing diabetes and control the status of diabetes.The HbA1c analyzer is specifically designed to be used with the corresponding test strip.
Catalog Number
A1C-M21
Brand Name
BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer
Version/Model Number
A1C EZ 2.0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 26, 2022
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
be0845eb-8729-43a2-a5a6-5b10951ce3b3
Public Version Date
August 30, 2022
Public Version Number
3
DI Record Publish Date
May 25, 2021
Package DI Number
16935784400016
Quantity per Package
24
Contains DI Package
06935784400019
Package Discontinue Date
August 26, 2022
Package Status
Not 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 |