| Primary Device ID | B502BSB56590 | 
| NIH Device Record Key | cddb6cf4-f04c-4086-822f-d73968dd0f4b | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Tinto IgA MMab | 
| Version Model Number | Predilute, 3 ml | 
| Catalog Number | BSB 5659 | 
| 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 | B502BSB56590 [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 | 2020-06-23 | 
| Device Publish Date | 2020-06-15 | 
| B502BSB56610 | Tinto IgA is a mouse monoclonal antibody derived from cell culture supernatant that is concentra | 
| B502BSB56600 | Tinto IgA is a mouse monoclonal antibody derived from cell culture supernatant that is concentra | 
| B502BSB56590 | Tinto IgA is a mouse monoclonal antibody derived from cell culture supernatant that is concentra |