Duns Number:753184944
Device Description: BOND Mixing Station contains six cavities that are used to mix shortlife reagents that mus BOND Mixing Station contains six cavities that are used to mix shortlife reagents that must be mixed just before use. The mixing of the reagents is determined by thesoftware, depending on reagent type.
Catalog Number
S21.1971
Brand Name
BOND
Version/Model Number
BOND Mixing Stations (5 pack)
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
145f196c-b2b7-40ab-81bb-4c194b3037b4
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 |