Duns Number:753184944
Device Description: The BOND system is designed for immunostaining histological specimens mounted on microscop The BOND system is designed for immunostaining histological specimens mounted on microscope slides.
Catalog Number
91.0021
Brand Name
BOND-PRIME automated stainer
Version/Model Number
BOND-PRIME
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
KPA
Product Code Name
Slide Stainer, Automated
Public Device Record Key
f2adc7e5-e4b2-4eaa-bf61-9bc0c1d82585
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
November 12, 2021
Package DI Number
09349458004835
Quantity per Package
1
Contains DI Package
09349458004828
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 28 |