Duns Number:528192913
Device Description: GluCoA1c Blood Glucose Test Strips, 50 Tests/Kit. Intended use: The GluCoA1c blood glucos GluCoA1c Blood Glucose Test Strips, 50 Tests/Kit. Intended use: The GluCoA1c blood glucose test strips are for use with the GluCoA1c analyzer to quantitatively measure the glucose level of fresh capillary whole blood. Contents: 50 test strips; package insert.
Catalog Number
GLU-S22
Brand Name
BioHermes GluCoA1c Blood Glucose Test Strips
Version/Model Number
GLU-A1C S04
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
fc297b54-f51c-47f7-963e-327e15d3c5ac
Public Version Date
November 03, 2021
Public Version Number
2
DI Record Publish Date
May 25, 2021
Package DI Number
16935784400054
Quantity per Package
120
Contains DI Package
06935784400057
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 |