BEUDAMED
    89 results · 15ms · Sources: EU EUDAMED, US FDA

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    ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 7, 2020

    DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    BZO Strip Dip Card (300ng/ml)*, Item No. 100170

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    EDI BZO Uncut Sheet - Cup*, Item No. 160170

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup¿ DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/BUPG/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC/TCA Bl, Cr, Ni, pH, SG", I-DXA-1127-023-N "Alere" iCup¿ Dx Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+ (OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G."

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 7, 2020

    Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Sheet Cup /189028, 160170/ EDI BZO Uncut Sheet-Cup/ 189081, 160120/ EDI MET1000 Uncut Sheet-Cup/ 189082, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189123, 160130/ EDI COC Uncut Sheet-Cup/ 189124, 160160/ EDI OPI2000 Uncut Sheet-Cup/ 189166, 160163/ EDI OPI (300) Uncut Sheet-Cup/ 189191, 160110/ EDI AMP Uncut Sheet-Cup/ 189371, 160140/ EDI THC Uncut Sheet Cup/ 189372, 160123/ EDI MET(300) Uncut Sheet-Cup/ 189425, 160170/ EDI BZO Uncut Sheet-Cup/ 189426, 100163/ EDI OPI (300) Uncut Sheet-Card/ 189456, 160170/ EDI BZO Uncut Sheet-Cup/ 189565, 160180/ EDI PCP Uncut Sheet-Cup/ 189601, 160125/ EDI MET(500) Uncut Sheet-Cup/ 189748, 160130/ EDI COC Uncut Sheet-Cup/ 189786, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189844, 160180/ EDI PCP Uncut Sheet-Cup/ 189937, 160172/ EDI BZO(200) Uncut Sheet-CUP/189956 Updated 09/03/2020: EDI Affected products -Catalog Numbers/ Lot Numbers 31105-3/ PI-01081 60503s-3ZC/ PH-10132 60600/ PH-11005

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 7, 2020

    10-Panel Pipette Drug Screen, Item No. PSP-10M

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    ProScreen 12 Panel Dip Card, Item No. PSD-12BUP

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    DrugSmart 9 Test Cup (BUP), Item No. 60960D

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    11 Panel Card (OPI 300) w/Adult, Item No. 71125AA

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    1 Step 12 Panel Cup, Item No. NBCA-12M-W

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015