Duns Number:835772872
Device Description: The A1CNow® Self Check Test System provides quantitative measurement of the percent of gly The A1CNow® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
Catalog Number
3070
Brand Name
A1CNow® Self Check Test System
Version/Model Number
3070
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090413,K090413
Product Code
LCP
Product Code Name
ASSAY, GLYCOSYLATED HEMOGLOBIN
Public Device Record Key
f51811cd-7539-49c6-87b1-6253e129a1b2
Public Version Date
April 14, 2022
Public Version Number
2
DI Record Publish Date
August 10, 2018
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |