Duns Number:397134693
Device Description: The DNA Positive Control Probe is intended for use as a positive control in formalin-fixed The DNA Positive Control Probe is intended for use as a positive control in formalin-fixed, paraffin-embedded tissue by DNA in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
Catalog Number
PB0682
Brand Name
BOND™
Version/Model Number
PB0682
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
6ba4e8e6-d489-4732-bc92-57a93129c604
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 |