FDA.report

Melanoma KBA.62 MMab

Primary DI
B502BSB69080
Brand
Melanoma KBA.62 MMab
Company
BIO SB, INC.
Model
Concentrate, 0.1 ml
Catalog number
BSB 6908
Device description
Melanoma KBA.62 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
Published
2020-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications

CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B502BSB69080PrimaryHIBCC0

GMDN Terms

TermDefinition
Multiple melanoma marker IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple markers associated with melanoma [e.g., tyrosinase, Melan-A/MART-1 peptide and/or glycoprotein 100 (gp100)] in a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
102855447
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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