Duns Number:397134693
Device Description: Anti-Fluorescein Antibody is intended for use with fluorescein-labeled nucleic acid probes Anti-Fluorescein Antibody is intended for use with fluorescein-labeled nucleic acid probes bound to specific nucleotide sequences in formalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
Catalog Number
AR0833
Brand Name
BOND™
Version/Model Number
AR0833
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
PPM
Product Code Name
General Purpose Reagent
Public Device Record Key
2e937406-af50-453a-9590-4b8ee7a12fc2
Public Version Date
April 19, 2021
Public Version Number
1
DI Record Publish Date
April 09, 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 |