Duns Number:833074623
Device Description: HPV E6, E7 mRNA Probe is specific for Human Papillomavirus types 16 and 18 E6,E7 mRNA. HPV HPV E6, E7 mRNA Probe is specific for Human Papillomavirus types 16 and 18 E6,E7 mRNA. HPV E6,E7 genes are transcribed as a single transcript using a common promoter and early polyadenylation site. HPV E6, E7 mRNA Probe is comprised of a cocktail of 85% pure full-length dual fluorescein-labelled molecules as verified by Reverse Phase HPLC.
Catalog Number
C31100
Brand Name
HPV E6, E7 mRNA Probe
Version/Model Number
C31100
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
25ff6a99-dbc6-4f52-97bd-71ae15a87c8f
Public Version Date
November 21, 2019
Public Version Number
2
DI Record Publish Date
September 19, 2019
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 | 4 |