| Primary Device ID | 05414470816637 |
| NIH Device Record Key | d1f9da85-a01b-45ca-af5d-ff54f3f52108 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INNO-LiPA HCV 2.0 Amp |
| Version Model Number | 81663 |
| Company DUNS | 297346645 |
| Company Name | Fujirebio Europe |
| 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 | 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 |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414470816637 [Primary] |
| OBF | Assay, Genotyping, Hepatitis C Virus |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-09 |
| Device Publish Date | 2025-05-30 |
| 05414470816637 | 81663 |
| 05414470816606 | 81660 |