Duns Number:515324122
Device Description: Hemoglobin A1c test kit. Intended use: For determination of hemogobin A1c in human whole b Hemoglobin A1c test kit. Intended use: For determination of hemogobin A1c in human whole blood including diagnosis. COntetns: 15 test cartridges, 1 package insert.
Catalog Number
1116794
Brand Name
Afinion HbA1c Dx
Version/Model Number
1116794
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
K182988
Product Code
PDJ
Product Code Name
Hemoglobin A1c Test System
Public Device Record Key
5e155060-a02f-46f0-a07a-8bc61a6f3cf7
Public Version Date
June 10, 2019
Public Version Number
1
DI Record Publish Date
May 31, 2019
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |