| Primary Device ID | 00695684016005 |
| NIH Device Record Key | 9a721103-333c-417f-a379-c3c17267201e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FEBRILE POSITIVE CONTROL |
| Version Model Number | 1600 |
| 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 | true |
| OTC Over-The-Counter | false |
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