| Primary Device ID | L502BSB3011 | 
| NIH Device Record Key | 9e914a6c-8f95-4f2d-bff5-bc3b9fce7316 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | IgE / FITC RPab | 
| Version Model Number | Concentrate, 1 ml | 
| Catalog Number | BSB 3011 | 
| 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 | false | 
| 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 | L502BSB3011 [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 | 2020-03-24 | 
| Device Publish Date | 2020-03-16 | 
| L502BSB3011 | The IgE/FITC is a purified rabbit polyclonal antibody labeled with FITC diluted in a Tris Buffer | 
| L502BSB30111 | The IgE/FITC is a purified rabbit polyclonal antibody labeled with FITC diluted in a Tris Buffer | 
| B502BSB3011050 | IgE/FITC is a purified rabbit polyclonal antibody labeled with FITC diluted in a Tri-sBuffered S |