BEUDAMED
    21 results · 64ms · 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 Regulation: Us FDA ×

    Response Biomedical Corp.

    FDA registration
    Response Biomedical Corp.·7 products·🇨🇦 Canada

    RAMP® Flu A + B TEST KIT; 25 TESTS

    FDA UDI
    Response Biomedical Corp·10627966005176·The RAMP® Flu A + B test is a qualitative immun...

    RAMP® RSV Control Swabs

    FDA UDI
    Response Biomedical Corp·10627966005206·The RAMP® RSV control swabs are additional exte...

    RAMP® NT-proBNP TEST KIT; 25 TESTS

    FDA UDI
    Response Biomedical Corp·10627966005046·The RAMP® NT-proBNP test is a quantitative immu...

    RAMP® Myoglobin TEST KIT; 25 TESTS

    FDA UDI
    Response Biomedical Corp·10627966005022·The RAMP® Myoglobin test is a quantitative immu...

    RAMP® CARDIAC CONTROLS; LEVEL 2

    FDA UDI
    Response Biomedical Corp·10627966005084·The RAMP® Cardiac Controls are prepared from hu...

    RAMP® CARDIAC CONTROLS; LEVEL 3

    FDA UDI
    Response Biomedical Corp·10627966005091·The RAMP® Cardiac Controls are prepared from hu...

    RAMP® Flu A + B Control Swabs

    FDA UDI
    Response Biomedical Corp·10627966005190·The RAMP® Flu A + B control swabs are additiona...

    RAMP® 1 Clinical Reader System

    FDA UDI
    Response Biomedical Corp·10627966005220·The RAMP® System is a rapid, quantitative immun...

    RAMP® 200 TM Test Module

    FDA UDI
    Response Biomedical Corp·10627966005244·RAMP® 200 Test Module analyzes sample tests

    RAMP® 200 CM Control Module

    FDA UDI
    Response Biomedical Corp·10627966005237·RAMP® 200 Control Module manages the sample tes...

    RAMP® RSV TEST KIT; 25 TESTS

    FDA UDI
    Response Biomedical Corp·10627966005183·The RAMP® RSV test is a qualitative immunochrom...

    RAMP® CK-MB TEST KIT; 25 TESTS

    FDA UDI
    Response Biomedical Corp·10627966005015·The RAMP® CK-MB test is a quantitative immunoch...

    RAMP® Troponin I TEST KIT; 25 TESTS

    FDA UDI
    Response Biomedical Corp·10627966005008·The RAMP® Troponin I test is a quantitative imm...

    RAMP® Cardiac Controls - Level 2

    FDA UDI
    Response Biomedical Corp·10627966005305·The RAMP® Cardiac Controls are prepared from hu...

    RAMP® CARDIAC CONTROLS; LEVEL 1

    FDA UDI
    Response Biomedical Corp·10627966005077·The RAMP® Cardiac Controls are prepared from hu...

    RAMP® Cardiac Controls - Level 1

    FDA UDI
    Response Biomedical Corp·10627966005299·The RAMP® Cardiac Controls are prepared from hu...

    Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP¿ platform.

    FDA Enforcement
    Class II ·Terminated·Response Biomedical Corp.·March 18, 2020

    Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP platform.

    FDA Recall
    Terminated ·Response Biomedical Corp. 1781 75th Ave W Vancouver Canada·Product code JJY·March 15, 2019

    NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER

    FDA Adverse Event
    Other ·NOVA BIOMEDICAL·Product code CGA·November 18, 2009