Duns Number:021192653
Device Description: AS-807 Campylobacter-Thioglycollate Medium (CAMPY-THIO) is used as a selective growth enri AS-807 Campylobacter-Thioglycollate Medium (CAMPY-THIO) is used as a selective growth enrichment broth for Campylobacter species from contaminated sources. Pre-reduced anaerobically sterilized (PRAS). 7 mL fill volume. 16 x 100 mm hungate-capped tubes. Transparent light yellow liquid with a marble chip. 10 tubes per pack.
Catalog Number
AS-807
Brand Name
PRAS Campylobacter-Thioglycollate Medium (CAMPY-THIO)
Version/Model Number
AS-807
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
JSJ
Product Code Name
Culture Media, Selective And Non-Differential
Public Device Record Key
b79a1a84-ccde-4b44-896d-682e44c5a69e
Public Version Date
May 11, 2020
Public Version Number
1
DI Record Publish Date
May 01, 2020
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 | 148 |