Duns Number:080131636
Catalog Number
-
Brand Name
Human CD80 (B7-1, BB1) FITC Conjugate
Version/Model Number
MHCD8001
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)
Yes
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
979ded50-8e34-46fb-9fa8-2f0b8f522d7a
Public Version Date
September 28, 2018
Public Version Number
2
DI Record Publish Date
May 16, 2018
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 | 634 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |
3 | A medical device with high risk that requires premarket approval | 12 |