| Primary Device ID | 06974521006619 |
| NIH Device Record Key | 9b4cb99d-b6b5-4297-b288-f613ef808d60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | U-Catch Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) |
| Version Model Number | 25 Tests/Kit |
| Catalog Number | YRLF065025 |
| Company DUNS | 724542368 |
| Company Name | Shenzhen Superbio Technology Co., Ltd. |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06974521006619 [Primary] |
| DJG | Enzyme Immunoassay, Opiates |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-30 |
| Device Publish Date | 2023-03-22 |
| 06974521002239 - S-Trust Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) | 2023-03-30 |
| 06974521002246 - Superbio Immunofluorescence Analyzer | 2023-03-30 |
| 06974521006619 - U-Catch Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) | 2023-03-30 |
| 06974521006619 - U-Catch Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) | 2023-03-30 |
| 06974521006626 - Bioeasy Immunofluorescence Analyzer | 2023-03-30 |