Duns Number:102855447
Device Description: HMB-45 & Mart-1 & Tyrosinase comprise a mouse monoclonal antibody cocktail derived from ce HMB-45 & Mart-1 & Tyrosinase comprise a mouse monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buff er pH 7.5
Catalog Number
BSB 6881
Brand Name
Melanoma Cocktail: HMB-45 Mart-1 & Tyrosinase MMab
Version/Model Number
Concentrate, 0.5 ml
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
NJT
Product Code Name
Immunohistochemistry Reagents And Kits
Public Device Record Key
1787c6fc-8ba8-4203-821b-d3157321c2e2
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 | 3887 |