| Primary Device ID | B502BSB237430 |
| NIH Device Record Key | 9ee371de-22f7-47e5-9371-667f532accb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tinto PRAME, RMab |
| Version Model Number | Predilute, 3 ml |
| Catalog Number | BSB-2374-3 |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | B502BSB237430 [Primary] |
| NJT | Immunohistochemistry Reagents And Kits |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-09 |
| Device Publish Date | 2020-10-30 |
| 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 |