Duns Number:078294784
Device Description: PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagati PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory. PCRopsis™ UVT (3 mL) is aliquoted into 100x sterile, 10 mL transport tubes.
Catalog Number
88810003
Brand Name
PCRopsis
Version/Model Number
Universal Viral Transport (100x 3 mL)
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 01, 2020
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
JSM
Product Code Name
Culture Media, Non-Propagating Transport
Public Device Record Key
6b4a7d75-e32f-40fa-a7c4-b074e982c9ec
Public Version Date
March 18, 2021
Public Version Number
2
DI Record Publish Date
October 29, 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 | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |