| Primary Device ID | 00850031114005 |
| NIH Device Record Key | 460e0ed1-51a4-4361-ba34-e905f4000f4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bulk Analyzer Reagent Pack |
| Version Model Number | 01-10019 |
| Company DUNS | 079715313 |
| Company Name | Selux Diagnostics, Inc. |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850031114005 [Primary] |
| LTW | Susceptibility Test Cards, Antimicrobial |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-30 |
| Device Publish Date | 2024-12-20 |
| 00195893563760 - Selux AST System | 2024-12-30 |
| 00850031114005 - Bulk Analyzer Reagent Pack | 2024-12-30 |
| 00850031114005 - Bulk Analyzer Reagent Pack | 2024-12-30 |
| 10850031114026 - Selux AST Gram Negative Panel | 2024-12-30 |
| 00850031114036 - AST Inoculator | 2024-12-30 |
| 00850031114043 - AST Analyzer | 2024-12-30 |
| 00850031114067 - PBC Separator with Selux AST System | 2024-12-30 |
| 10850031114149 - Selux Seaparator Reagent Kit | 2024-12-30 |
| 00850031114135 - Selux AST Gram Positive Panels | 2024-12-25 |