| Primary Device ID | 00858022006230 |
| NIH Device Record Key | a6267b2c-a5c9-4b29-8c5e-78b8d641a88f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AdexusDx hCG Control Set (unassayed) |
| Version Model Number | 401.009 |
| Catalog Number | 401.009 |
| Company DUNS | 079541513 |
| Company Name | NOWDIAGNOSTICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858022006230 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-22 |
| Device Publish Date | 2023-02-14 |
| 10858022006015 - First To Know Syphilis Test | 2024-12-17 25 count convenience pack |
| 00858022006001 - First To Know Syphilis Test | 2024-11-19 Inner package containing one-count device |
| 00858022006230 - AdexusDx hCG Control Set (unassayed) | 2023-02-22hCG Control Set (unassayed) |
| 00858022006230 - AdexusDx hCG Control Set (unassayed) | 2023-02-22 hCG Control Set (unassayed) |
| 00858022006193 - AdexusDx hCG Test | 2018-07-06 Box of one test cartridge |
| 00858022006209 - AdexusDx hCG Test | 2018-07-06 Box of 25 cartridges/tests |
| 00858022006216 - AdexusDx hCG Test | 2018-07-06 Box of 50 cartridges/tests |