Duns Number:122561087
Device Description: BD Density Reagent (480mL)
Catalog Number
491332
Brand Name
BD Density Reagent (480 ml)
Version/Model Number
491332
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
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
ba5a9968-e441-4e65-aa3b-43c8026ad242
Public Version Date
July 11, 2019
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 611 |
2 | A medical device with a moderate to high risk that requires special controls. | 614 |
3 | A medical device with high risk that requires premarket approval | 36 |
U | Unclassified | 4 |