Duns Number:605213545
Device Description: A highly selective growth medium which maintains viable Trichomonas vaginalis cultures (po A highly selective growth medium which maintains viable Trichomonas vaginalis cultures (positive controls) for up to seven (7) days.
Catalog Number
21-051-001
Brand Name
InPouch® TVC Subculture
Version/Model Number
1051
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
d7da8131-cd0b-4913-aaa8-5f1b52e82ff6
Public Version Date
May 07, 2019
Public Version Number
2
DI Record Publish Date
September 12, 2018
Package DI Number
B08810513
Quantity per Package
10
Contains DI Package
B08810510
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box