Duns Number:753184944
Device Description: The BOND-ADVANCE Controller provides the computer that contains the software (version 7.0) The BOND-ADVANCE Controller provides the computer that contains the software (version 7.0) that controls the Processing Module(s).Used in BOND multi seatconfigurations.
Catalog Number
49.4526
Brand Name
BOND
Version/Model Number
BOND-ADVANCE Controller (7.0)
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
0152be1a-da78-4963-99bc-910d0f5b64c4
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 |