Duns Number:397134693
Device Description: HPV Probe (Subtypes 16, 18, 31, 33, 51) is intended to be used for the qualitative identif HPV Probe (Subtypes 16, 18, 31, 33, 51) is intended to be used for the qualitative identification of the Human Papillomavirus (HPV) DNAin formalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAXsystem and Leica BOND-III system). This probe binds to the five high risk HPV subtypes, 16, 18, 31, 33 and 51.
Catalog Number
PB0829
Brand Name
BOND™
Version/Model Number
PB0829
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
-
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
07e48681-8651-4e29-8163-17df852cdeaa
Public Version Date
March 29, 2021
Public Version Number
1
DI Record Publish Date
March 19, 2021
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 | 365 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| 3 | A medical device with high risk that requires premarket approval | 1 |