Duns Number:305684449
Device Description: Rabbit antisera. Ready-To-Use.
Catalog Number
53828
Brand Name
Salmonella Phase H:g,s,t serum, 3 mL
Version/Model Number
53828
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 03, 2016
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
GRM
Product Code Name
Antisera, All Groups, Salmonella Spp.
Public Device Record Key
5ffe574a-3ec3-4d57-ae0e-30b80fb904d6
Public Version Date
June 10, 2021
Public Version Number
3
DI Record Publish Date
September 13, 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 | 1152 |
2 | A medical device with a moderate to high risk that requires special controls. | 272 |