| Primary Device ID | 10810124273221 |
| NIH Device Record Key | dfb1f3c1-1cf4-40bd-b170-9a16bd5fe768 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SureStepTM Urine Test Drug Screen Strip, Opiate (OPI 2000) |
| Version Model Number | DMO-101-a-Sgl |
| Company DUNS | 194854949 |
| Company Name | ALERE SAN DIEGO, INC. |
| Device Count | 50 |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810124273224 [Primary] |
| GS1 | 10810124273221 [Unit of Use] |
| 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 | 2023-12-25 |
| Device Publish Date | 2023-12-15 |
| 10810124272972 - CERTUM One Step Multi-Line Drug Screen EZ Split | 2024-10-18 ++< mAMP1000>++ + |
| 10810124273795 - CERTUM One Step Multi-Line Drug Screen EZ Split | 2024-10-18 ++< THC50> |
| 10810124273801 - CERTUM One Step Multi-Line Drug Screen EZ Split | 2024-10-18 ++++ |
| 10810124273818 - CERTUM One Step Multi-Line Drug Screen EZ Split | 2024-10-18 ++< mAMP1000>++ + |
| 10810124273825 - CERTUM One Step Multi-Line Drug Screen EZ Split | 2024-10-18 (AMP1000/COC300/THC50)+( mAMP1000/OPl2000/PCP25)+(BZO300/TCA1000/BAR300)+ |
| 10810124274518 - CERTUM One Step Multi-Line Drug Screen EZ Split | 2024-10-18 ++++ |
| 10810124273146 - SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup | 2024-09-25 ++++ |
| 10810124273153 - SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup | 2024-09-25 +++++ |