Duns Number:753184944
Device Description: The BOND System Control Kit provides the computer which contains the software (version 6.0 The BOND System Control Kit provides the computer which contains the software (version 6.0/W10 IoT) that controls the Processing Modules(s), as well asthe Slide Labeler, Handheld barcode scanner, ethernet switch and power cable.
Catalog Number
21.2793
Brand Name
BOND
Version/Model Number
BOND System Control Kit (6.0/W10 loT)
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)
-
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
ffa9a16e-023d-4ebb-9f07-6747612ec347
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 |