| Primary Device ID | 10858022006015 |
| NIH Device Record Key | c79c0685-9a4f-4ec3-a481-d8d97627b479 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | First To Know Syphilis Test |
| Version Model Number | 8057-25-CP |
| Catalog Number | 8057-25-CP |
| Company DUNS | 079541513 |
| Company Name | NOWDIAGNOSTICS, INC. |
| Device Count | 25 |
| 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 | false |
| OTC Over-The-Counter | true |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858022006018 [Primary] |
| GS1 | 10858022006015 [Unit of Use] |
| SBZ | Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-17 |
| Device Publish Date | 2024-12-09 |
| 00858022006001 | Inner package containing one-count device |
| 10858022006015 | 25 count convenience pack |