Duns Number:835772872
Device Description: The A1CNow®+ Multi-Use Test System provides quantitative measurement of the percent of gly The A1CNow®+ Multi-Use Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
Catalog Number
3021
Brand Name
A1CNow®+ Multi-UseTest System (20 count)
Version/Model Number
3021
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)
Yes
Over the Counter (OTC)
-
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
f7e54125-fc90-4ee3-8045-5e2fe2ce1056
Public Version Date
April 14, 2022
Public Version Number
5
DI Record Publish Date
August 05, 2016
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 |