| Primary Device ID | 00695684971014 |
| NIH Device Record Key | 8a7823ef-ba18-4c9c-a47f-750234a132b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pregcolor Premium |
| Version Model Number | 97101PCP |
| Company DUNS | 176458115 |
| Company Name | GERMAINE LABORATORIES, 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 | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| 10695684423381 - AimScreen Fentanyl | 2024-04-09 |
| 00695684893019 - Pregcolor Plus | 2023-08-17 |
| 00695684971014 - Pregcolor Premium | 2023-08-17 |
| 00695684971014 - Pregcolor Premium | 2023-08-17 |
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| 00695684444310 - SAFECUP III 13 PANEL | 2022-08-25 |
| 00695684754075 - Mosie Baby Ovulation Test | 2020-01-31 Urine Midstream. Rapid qualitative test to detect the LH surge in urine. Designed to aid in the prediction of ovulation, for sel |
| 00695684957018 - Mosie Baby Pregnancy Test | 2020-01-31 Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Designed for self testing (home). Results withi |
| 06956847540756 - Mosie Baby Ovulation Test | 2019-10-29 Urine Midstream. Rapid qualitative test to detect the LH surge in urine. Designed to aid in the prediction of ovulation, for sel |