Duns Number:039981550
Device Description: Viral Transport Medium VTM, 3.1ml fill (swabs sold separately), order by the package of 20 Viral Transport Medium VTM, 3.1ml fill (swabs sold separately), order by the package of 20Hardy Diagnostics Viral Transport Medium is recommended for the collection and transport of clinical specimens for the recovery of viral agents including, but not limited to, Herpes Simplex Type I, Herpes Simplex Type II, Cytomegalovirus (CMV), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), Echovirus, Adenovirus, etc.
Catalog Number
R99
Brand Name
N/A
Version/Model Number
R99
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
K955451,K955451
Product Code
JSM
Product Code Name
Culture Media, Non-Propagating Transport
Public Device Record Key
c55f8319-608e-4cb3-b6a9-5b2a325cbff2
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
June 05, 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 |