| Primary Device ID | B35000400R0 |
| NIH Device Record Key | ddb57926-b558-427b-a81e-7eed0262fc7c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AIX1000 Analyzer |
| Version Model Number | 00400R |
| Catalog Number | 00400R |
| Company DUNS | 790524891 |
| Company Name | Gold Standard Diagnostics Corporation |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 |
|---|---|
| HIBCC | B35000400R0 [Primary] |
| GMQ | Antigens, Nontreponemal, All |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-08 |
| Device Publish Date | 2023-10-31 |
| B350GSD051600MW0 - Microtiterplates (5) | 2024-10-30 Microtiterplates (5) |
| B35000300CLR0 - ThunderBolt EIA (CLIA) | 2023-11-08 ThunderBolt EIA-CLIA (refurbished) |
| B35000300R0 - ThunderBolt EIA | 2023-11-08 ThunderBolt EIA (refurbished) |
| B35000400R0 - AIX1000 Analyzer | 2023-11-08AIX1000 Rapid Plasma Reagin (RPR) Analyzer (refurbished) |
| B35000400R0 - AIX1000 Analyzer | 2023-11-08 AIX1000 Rapid Plasma Reagin (RPR) Analyzer (refurbished) |
| B35000500CLR0 - Bolt (CLIA) | 2023-11-08 Bolt EIA-CLIA (refurbished) |
| B35000500R0 - Bolt | 2023-11-08 Bolt EIA (refurbished) |
| B350GSD011600DYE0 - AIX1000 Performance Check Dye Kit | 2023-09-21 AIX1000 Performance Check Dye Kit |
| B350GSD0124500 - Performance Check Dye Kit | 2023-09-21 Performance Check Dye Kit |