Duns Number:103318015
Device Description: BD PrepStain™ Consumables Kit: BD SurePath™ PreCoat Slides (5 X 96), BD PrepStain™ Transf BD PrepStain™ Consumables Kit: BD SurePath™ PreCoat Slides (5 X 96), BD PrepStain™ Transfer Tips (5 X 96), & BD Settling Chambers (2 X 240)
Catalog Number
491311
Brand Name
BD PrepStain™ Consumables Kit
Version/Model Number
491311
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 26, 2020
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
Yes
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
P970018
Product Code
MKQ
Product Code Name
Processor, Cervical Cytology Slide, Automated
Public Device Record Key
fe675f36-810c-4888-9f97-c032fc0a1dec
Public Version Date
October 26, 2020
Public Version Number
5
DI Record Publish Date
September 08, 2017
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 |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 17 |