Duns Number:176458115
Device Description: Febrile Controls are intended for use as positive & negative controls for these tests.
Catalog Number
-
Brand Name
SALMONELLA H POLY POSITIVE CONTROL
Version/Model Number
1606
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
GSN
Product Code Name
Antiserum, Positive And Negative Febrile Antigen Control Serum
Public Device Record Key
5e6792c3-2d65-4b90-bf1a-479cde690f3c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 21, 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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |