| Primary Device ID | 10743816001218 |
| NIH Device Record Key | e07cd152-b994-400d-bd58-6dbbd30f990c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Status Flu A+B card |
| Version Model Number | BSP-510-04-00 |
| Catalog Number | BSP-510-04-00 |
| Company DUNS | 362917692 |
| Company Name | PRINCETON BIOMEDITECH CORPORATION |
| 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 | true |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10743816001218 [Primary] |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2016-09-23 |
| 10743816001508 | Status Flu A+B; 25 Test Kit |
| 10743816001218 | Status Flu A & B; 4 Test Sample Kit |
| 10743816001195 | Status Flu A+B; 22 Test Kit |