Duns Number:024230633
Device Description: BD Multitest 6-Color TBNK Reagent IVD
Catalog Number
644611
Brand Name
BD Multitest™
Version/Model Number
644611
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 15, 2021
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
K090967
Product Code
GKZ
Product Code Name
Counter, differential cell
Public Device Record Key
34cd2ba0-90d0-403f-ac6c-92cb5b6ee9ff
Public Version Date
April 19, 2021
Public Version Number
4
DI Record Publish Date
June 08, 2016
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 |