Duns Number:012430880
Device Description: Rapid test for the quantitative detection of Influenza A&B antigens in nasal swab specimen Rapid test for the quantitative detection of Influenza A&B antigens in nasal swab specimens
Catalog Number
1126219
Brand Name
Henry Schein
Version/Model Number
1126219
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
GNX
Product Code Name
ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
Public Device Record Key
5e450dca-df9d-49f7-97ea-1410b9d9c414
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10304040019778
Quantity per Package
27
Contains DI Package
00304040019771
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |