| Primary Device ID | B110CB33120 |
| NIH Device Record Key | 7d07376b-6bae-4853-b4fe-0a5ce1698c14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coxsackie B1-6 Screen Virus Antigen Substrate, 12 wells, For IFA Test System |
| Version Model Number | CB-3312 |
| Catalog Number | CB-3312 |
| Company DUNS | 024824641 |
| Company Name | Bion Enterprises, Ltd. |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |