| Primary Device ID | 00695684131128 |
| NIH Device Record Key | d7176cf8-0d3d-477f-a825-89579bdfa43d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KETONE SERUM CONTROLS |
| Version Model Number | 13112 |
| Company DUNS | 176458115 |
| Company Name | GERMAINE LABORATORIES, 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 |
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| 00695684444310 - SAFECUP III 13 PANEL | 2022-08-25 |
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| 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 |