Duns Number:322209263
Catalog Number
-
Brand Name
Anti-Influenza A/B Virus Pool ELISA (IgG)
Version/Model Number
EI 2691-9601-1 G
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 2018
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
GNS
Product Code Name
Antisera, Hai, Influenza Virus A, B, C
Public Device Record Key
ed12c8d9-911e-4d93-9f3f-a5bb4c5a8370
Public Version Date
September 03, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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 | 115 |
2 | A medical device with a moderate to high risk that requires special controls. | 213 |