| Primary Device ID | B350004000 |
| NIH Device Record Key | 8dc581b9-91f9-484d-9731-e4bdc3ab8a8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AIX1000 Analyzer |
| Version Model Number | 00400 |
| Company DUNS | 790524891 |
| Company Name | GOLD STANDARD DIAGNOSTICS CORP. |
| 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 | B350004000 [Primary] |
| GMQ | Antigens, Nontreponemal, All |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-29 |
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