Duns Number:515324122
Device Description: HbA1c Contols for use with the Alere Afinion HbA1c test and Afinion HbA1c test. Content: 1 HbA1c Contols for use with the Alere Afinion HbA1c test and Afinion HbA1c test. Content: 1 Control C1. 1 Control C II. 1 package insert. DI covers Alere Afinion HbA1c Control and Afinion HbA1c Control.
Catalog Number
1115178
Brand Name
Alere Afinion HbA1c Control
Version/Model Number
1115178
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
-
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
5c7ffd08-2451-4cf4-9530-2d72dcae95a0
Public Version Date
May 09, 2019
Public Version Number
3
DI Record Publish Date
May 07, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |