Tinto PRAME, RMab BSB-2374-15

GUDID B502BSB2374150

Anti-PRAME is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5,

BIO SB, INC.

Melanoma specific protein IVD, antibody

• Primary Device ID: B502BSB2374150
• NIH Device Record Key: 3ef4b001-9826-401e-98d3-0c72921e1abb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tinto PRAME, RMab
• Version Model Number: Predilute, 15 ml
• Catalog Number: BSB-2374-15
• Company DUNS: 102855447
• Company Name: BIO SB, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B502BSB2374150 [Primary]

FDA Product Code

• NJT: Immunohistochemistry Reagents And Kits

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-09
• Device Publish Date: 2020-10-30

On-Brand Devices [Tinto PRAME, RMab]

• B502BSB237470: Anti-PRAME is a rabbit monoclonal antibody derived from cell culture supernatant that is concent
• B502BSB237430: Anti-PRAME is a rabbit monoclonal antibody derived from cell culture supernatant that is concent
• B502BSB2374150: Anti-PRAME is a rabbit monoclonal antibody derived from cell culture supernatant that is concent