Duns Number:008254708
Device Description: COULTER CLONE KC56 (T-200)-FITC (Analyte Specific Reagent)
Catalog Number
6603838
Brand Name
COULTER CLONE KC56 (T-200)-FITC
Version/Model Number
6603838
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
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
0573dab1-daa8-4746-babe-1511bf17dd46
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 2020
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 | 319 |
2 | A medical device with a moderate to high risk that requires special controls. | 503 |
3 | A medical device with high risk that requires premarket approval | 9 |
U | Unclassified | 1 |