7 results · 9ms · Sources: EU EUDAMED, US FDA

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Mycoplasma IgM ELISA 96 Well Kit, Catalog Number: MP021M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

FDA Recall
Terminated ·Calbiotech Inc·Product code LJZ·August 27, 2008

EBV VCA IgG ELISA 96 Well Kit, Catalog Number: EV010G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

FDA Recall
Terminated ·Calbiotech Inc·Product code LJZ·August 27, 2008

Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)

FDA Recall
Terminated ·Sakar International, Inc.·Product code DJZ·November 30, 2007

Mycoplasma IgG ELISA 96 Well Kit, Catalog Number: MP020G, The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

FDA Recall
Terminated ·Calbiotech Inc·Product code LJZ·August 27, 2008

0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp., Blairstown, NJ (general device assembly). Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box.

FDA Recall
Terminated ·WNCK, Inc·Product code DJZ·November 30, 2005

Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.

FDA Recall
Terminated ·Acon Laboratories, Inc.·Product code DJZ·June 17, 2015

The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.

FDA Recall
Terminated ·Meridian Bioscience Inc·Product code LJZ·February 8, 2021