| Primary Device ID | 00840733103285 |
| NIH Device Record Key | b8b48498-2d0b-41dc-830a-28fed6ef0a93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Revogene Check |
| Version Model Number | 610220 |
| Catalog Number | 610220 |
| Company DUNS | 092815364 |
| Company Name | MERIDIAN BIOSCIENCE, 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
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| 00840733103285 - Revogene Check | 2022-07-05 The Revogene Check is a single-use, qualitative test utilizing automated real-time Polymerase Chain Reaction (PCR) to confirm th |
| 00840733102844 - Para-Pak SAF | 2022-04-01 The Para-Pak SAF is a convenient system for the routine collection, transportation, preservation, and examination of stool speci |
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