| Primary Device ID | 10858945006635 |
| NIH Device Record Key | 8d0296e4-5739-4837-9648-1c7c968f8470 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AlereTM iScreen® OFD |
| Version Model Number | I-DCT-B702 |
| Company DUNS | 019410187 |
| Company Name | Instant Technologies, Inc. |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 30817405024118 - iScreen™ | 2024-08-14 iScreen 10 Panel CLIA Click Cup AMP1000, BAR300, BZO300, COC300, MET1000, MDMA500, MOP300, MTD300, OXY100, THC50 |
| 10817405024077 - iScreen™ Urine Test E-Z Split Key™ Drug Screen Cup | 2024-07-24 iScreen 9 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+++(MDMA/MTD)+(BZO/BAR)+(MET/OPI/PCP) |
| 10817405024084 - iScreen™ Urine Test E-Z Split Key™ Drug Screen Cup | 2024-07-24 iScreen 10 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+++(AMP/COC)+(MET/MOP/PCP)+(BZO/MTD/BAR) |
| 10817405024107 - iScreen™ Urine Test E-Z Split Key™ Drug Screen Cup | 2024-07-24 iScreen 8 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+++(MET/OPI/PCP)+(BZO/MTD/BAR) |
| 30817405024033 - iScreen™ | 2024-01-05 9 Panel Privacy EUO Oral Fluid COC20, OPI40, MDMA50, OXY20, THC40, 6AM/HRN10, MET50, AMP50, PCP10 |
| 30817405024040 - iScreen™ | 2024-01-05 11 Panel Privacy EUO Oral Fluid BUP5, AMP50, MDMA50, COC20, OXY20, BAR50, OPI40, BZO10, MET50, MTD30, THC40 |
| 30817405024057 - iScreen™ | 2023-12-15 5 Panel Privacy EUO Oral Fluid MET50, OXY20, OPI40, AMP50, COC20 |
| 30817405024064 - iScreen™ | 2023-12-15 6 Panel Masked EUO Oral Fluid AMP50, THC40, OXY20, COC20, MET50, OPI40 |