BEUDAMED
    137 results · 31ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement ×

    ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection: (COC300/THC50)+AMP1000+BZO300+BUP10+MET500+MTD300+OPI300 NO ADULTERATION", IMCA-8CM5 /"ImmuTest Drugs of Abuse Cup (OXY100/MDMA500)+(PCP25/AMP1000)+COC150+MET500+OPI2000+THC50 with Cr, Ni, pH, Bl, S.G."

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

    QuickTox 5 Panel Drug Screen DipCard

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 25, 2019

    Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W; Immutest 7 panel, Item No. IMCA-7P; ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P 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

    ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W

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

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

    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

    ProScreen 10 Panel Cup, Item No. PSCup-10M

    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

    THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU 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

    Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU 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

    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

    11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA 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

    ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 22, 2014

    ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO 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

    11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA 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

    ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W

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

    ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300

    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 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

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

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