Duns Number:753184944
Device Description: The BOND system automates clinical protocols for immunostaining of pathology specimens mou The BOND system automates clinical protocols for immunostaining of pathology specimens mounted on microscope slides. Microscope slides subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis.
Catalog Number
49.0051
Brand Name
BOND-MAX Processing Module
Version/Model Number
BOND-MAX
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
92df5d94-a96a-4072-abc8-673f64a534b6
Public Version Date
July 26, 2022
Public Version Number
1
DI Record Publish Date
July 18, 2022
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 | 28 |