Duns Number:305684449
Device Description: Reference strain
Catalog Number
82162
Brand Name
S. Paratyphi A reference strain
Version/Model Number
82162
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
GRL
Product Code Name
Antigens, All Groups, Salmonella Spp.
Public Device Record Key
3bf5f9af-fee7-4d99-943b-c87fb58e5d29
Public Version Date
August 05, 2021
Public Version Number
4
DI Record Publish Date
September 15, 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 |