Duns Number:179135769
Device Description: anti-Procollagen-1 Rat Monoclonal Antibody [M-58], Ready-To-Use, 15 mL
Catalog Number
60-0222-15
Brand Name
Genemed®
Version/Model Number
60-0222-15
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
ba19b2f6-f2ea-462f-81f5-9825b328f26e
Public Version Date
September 14, 2020
Public Version Number
1
DI Record Publish Date
September 05, 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 | 733 |