| Primary Device ID | 20817038021358 |
| NIH Device Record Key | 294b288e-e9e1-4a42-bb57-7ea3758a9f48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | u-Card Drug Test Screen |
| Version Model Number | U-DOA-6124L |
| Catalog Number | U-DOA-6124L |
| Company DUNS | 163610020 |
| Company Name | UCP BIOSCIENCES, INC. |
| Device Count | 25 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| 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 |
| 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 |
| 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 | 00817038021354 [Unit of Use] |
| GS1 | 10817038021351 [Primary] |
| GS1 | 20817038021358 [Package] Contains: 10817038021351 Package: case [40 Units] In Commercial Distribution |
| DJR | Enzyme Immunoassay, Methadone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-05-24 |
| Device Publish Date | 2017-01-20 |
| 20817038021907 | u-Card Drug Test Screen 11 Panel Test Card THC/COC/OPI/AMP/BZO/BAR/MET/OXY/MTD/BUP/TCA) |
| 20817038021853 | u-Card Drug Test Screen 5 panel Test Card(AMP/COC/OPI/PCP/THC) |
| 20817038021365 | 12 panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC with Adulteration strip(S.G |
| 20817038021358 | 12 panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC |
| 20817038021198 | THC Single Panel Dip Test Card |
| 20817038021167 | 10 panel Test Card AMP/BAR/BZO/COC/MET/MTD/OPI/OXY/PCP/THC |
| 20817038021150 | 6 panel Test Card AMP/BZO/COC/MET/OPI/THC |
| 20817038021143 | 5 panel Test Card AMP/COC/MET/OPI/THC |
| 20817038021877 | u-Card Drug Test Screen AMP Single Panel Dip Test Card |
| 20817038021846 | u-Card Drug Test Screen MOP Single Panel Dip Test Card |
| 20817038021839 | u-Card Drug Test Screen OXY Single Panel Dip Test Card |
| 20817038021822 | u-Card Drug Test Screen Opiates Single Panel Dip Test Card |
| 20817038021204 | BUP Single Panel Dip Test Card |
| 20817038022119 | MET Single Panel Dip Test Card |