| Primary Device ID | 00851458005075 |
| NIH Device Record Key | 46c2304c-164e-4825-a52b-54b48cfb20fa |
| Commercial Distribution Discontinuation | 2016-12-13 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | JBAIDS |
| Version Model Number | JRPD-ASY-0138 |
| Catalog Number | JRPD-ASY-0138 |
| Company DUNS | 556915205 |
| Company Name | BIOFIRE DEFENSE, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 801-262-3592 |
| support@biofiredefense.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851458005075 [Primary] |
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-12 |
| Device Publish Date | 2016-09-07 |
| 00851458005082 | JBAIDS IVD Influenza A/H5 Detection Kit |
| 00851458005075 | JBAIDS IVD Influenza A Subtyping Kit |
| 00851458005068 | JBAIDS IVD Influenza A & B Detection Kit |
| 00851458005044 | JBAIDS IVD Plague Detection Kit |
| 00851458005037 | JBAIDS IVD Anthrax Detection Kit |
| 00851458005020 | JBAIDS IVD Tularemia Detection Kit |
| 00851458005013 | JBAIDS IVD Q Fever Detection Kit |
| 00851458005006 | JBAIDS Instrument |