| Primary Device ID | B502BSB3009150 |
| NIH Device Record Key | b738ffa3-9339-4190-b1e6-46292cc0b4fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tinto Kappa / FITC RPab |
| Version Model Number | Predilute, 15 ml |
| Catalog Number | BSB 3009-15 |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | B502BSB3009150 [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 |
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