Duns Number:039981550
Device Description: Thio with supplements, 15mL, 20x125mm tube, 20 tubes/pack(Thioglycollate without indicator Thio with supplements, 15mL, 20x125mm tube, 20 tubes/pack(Thioglycollate without indicator, with hemin, vitamin K, and calcium carbonate chip as a buffer) For the cultivation of anaerobes and other fastidious bacteria. Filtered to remove dead bacteria and debris.
Catalog Number
K28
Brand Name
N/A
Version/Model Number
K28
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
JSG
Product Code Name
Culture Media, Non-Selective And Non-Differential
Public Device Record Key
f13acc80-4fba-4aa5-92f9-3aecced62917
Public Version Date
June 09, 2020
Public Version Number
1
DI Record Publish Date
June 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 | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |