Duns Number:212623821
Device Description: M14294 - Salmonella O Antiserum Polyvalent - Kauffmann White Schem Groups A to G - 1 pack M14294 - Salmonella O Antiserum Polyvalent - Kauffmann White Schem Groups A to G - 1 pack of 2ml
Catalog Number
M14294
Brand Name
Mast Assure Antisera
Version/Model Number
M14294
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
GRM
Product Code Name
Antisera, All Groups, Salmonella Spp.
Public Device Record Key
9b514b68-a2a2-4a7f-b113-33d229265f2a
Public Version Date
September 30, 2021
Public Version Number
1
DI Record Publish Date
September 22, 2021
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |