BEUDAMED
    203 results · 11ms · 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 Status: Terminated ×

    Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an outer box, a shrink-wrapped inner box that contains the blood collection card with an unique PIN, the instructions for use and ''Frequently Asked Questions'', a polybag component that includes two lancets, one gauze pad, one adhesive bandage and one alcohol prep pad, a specimen return envelope and a prepaid return mailer either designated as U.S. first class or FedEx; Home Access Health Corporation, Hoffman Estates, IL 60195-5200; UPC 0 83170 51000 5

    FDA Recall
    Terminated ·Home Access Health Corp (HAHC)·Product code MZO·October 6, 2006

    AxSYM Anti-HCV Reagent Pack; list 05C36; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code MZO·April 23, 2007

    VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it. Each Reagent Pack can test for 100 samples (patient, Quality Control, etc.).

    FDA Recall
    Terminated ·ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS Bridgend United Kingdom·Product code MZO·August 6, 2014

    ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code MZO·March 9, 2004

    OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.

    FDA Recall
    Terminated ·OraSure Technologies, Inc.·Product code MZO·January 15, 2016

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

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

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

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

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

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

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

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

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

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    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 Recall
    Terminated ·Ameditech Inc·Product code DKC·August 18, 2020

    ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

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

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

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

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

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

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

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

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015