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MEDTOX DIAGNOSTICS INC

MEDTOXSCAN · General Hospital

510(k): 3 Recall: 2 UDI: 15 MAUDE: 1 Class.: 66

510(k) Clearances (3)

PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM

2010-04-05

Substantially Equivalent

PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM

2009-07-24

Substantially Equivalent

MEDTOXSCAN

2009-02-13

Substantially Equivalent

Recalls (2)

PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,

2013-04-05

Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.

MEDTOXscan Reader

2008-02-08

Reader was marketed without a 510(k).

UDI Registrations (15)

MEDTOXScan® QC Test Devices

QC Test Devices used to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination. QC Test Devices are intended to function as an optical performance system check for the MEDTOXScan® Reader only, and not intended to replace the nee…

PROFILE®-V MEDTOXScan®

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, and Buprenorphine drugs and/or metabolites in human urine.

MEDTOXScan®

A micro pipette designed to dispense an accurate volume of sample for the PROFILE®-V MEDTOXScan® Test Devices.

PROFILE®-V MEDTOXScan®

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, and Barbiturates drugs and/or metabolites in human urine.

MEDTOXScan® Cleaning Cassette

A cleaning cassette solely intended to clean the color Contact Imaging Sensor (CIS) in the MEDTOXScan® Reader.

PROFILE®-V MEDTOXScan®

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Methadone, Barbiturates, and Oxycodone drugs and/or metabolites in human urine.

PROFILE®-V MEDTOXScan®

Positive toxicology urine control used to monitor and validate the performance of PROFILE®-V MEDTOXScan® drugs of abuse test devices.

PROFILE®-V MEDTOXScan®

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, and Propoxyphene drugs and/or metabolites in human urine.

PROFILE®-V MEDTOXScan®

Positive toxicology urine control used to monitor and validate the performance of PROFILE®-V MEDTOXScan® drugs of abuse test devices.

PROFILE®-V MEDTOXScan®

Positive toxicology urine control used to monitor and validate the performance of PROFILE®-V MEDTOXScan® drugs of abuse test devices.

PROFILE®-V MEDTOXScan®

Positive toxicology urine control used to monitor and validate the performance of PROFILE®-V MEDTOXScan® drugs of abuse test devices.

PROFILE®-V MEDTOXScan®

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepines, and Barbiturates drugs and/or metabolites in human urine.

PROFILE®-V MEDTOXScan®

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, and Oxycodone drugs and/or metabolites in human urine.

MEDTOXScan® Reader

An instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Devices, which are one-step immunochromatographic tests for the rapid, qualitative detection of one or more drugs in human urine.

PROFILE®-V MEDTOXScan®

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, Propoxyphene, and Buprenorphine drugs and/or metabolites in human urine.

MAUDE Adverse Events (1)

Injury

20071020

FDA Classification (66)

Digital Physical/Chemical Sterilization Process Sensor

General Hospital

Set, Blood Transfusion

General Hospital

Washer Of Body Waste Receptacles

General Hospital

Sterilizer, Dry Heat

General Hospital

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

General Hospital

Infusion Safety Management Software

General Hospital

Vascular Access Port Kit

General Hospital

Tubing, Fluid Delivery

General Hospital

Basin, Emesis

General Hospital

Oral Administration Set

General Hospital

Ear Irrigation Kit

General Hospital

Nursing Pad, Cohesive Gel

General Hospital

Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

General Hospital

Bottle, Collection, Vacuum

General Hospital

Thoracentesis Tray

General Hospital

Delivery Room Apparel Kit

General Hospital

Support, Scrotal, Therapeutic

General Hospital

Whole Room Microbial Reduction Device

General Hospital

Detectors And Removers, Lice, (Including Combs)

General Hospital

Accessories To Examination Light

General Hospital

Stocking, Medical Support (For General Medical Purposes)

General Hospital

Blood Borne Pathogen Response Kit

General Hospital

Strip, Temperature, Forehead, Liquid Crystal

General Hospital

Pump, Infusion, Pca

General Hospital

Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device

General Hospital

Stationary Infrared Thermometer

General Hospital

Depressor, Tongue, Non-Surgical

General Hospital

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

General Hospital

Low Dead Space Needle, Single Lumen, Hypodermic

General Hospital

Warmer, Infant Radiant

General Hospital

Tubing, Noninvasive

General Hospital

Administrations Sets With Neuraxial Connectors

General Hospital

Stapler, Surgical

General Hospital

Warmer, Thermal, Infusion Fluid

General Hospital

Rigid Sterilization Container With Software

General Hospital

Lubricant, Vaginal, Patient

General Hospital

Sterilizer, Steam

General Hospital

Mattress, Water, Temperature Regulated

General Hospital

Heparin Flush In 0.45% Sodium Chloride

General Hospital

Powder-Free Guayle Rubber Examination Glove

General Hospital

Thermometer Kit

General Hospital

Automated Endoscope Channel Cleaner

General Hospital

Cover, Mattress (Medical Purposes)

General Hospital

Fall Prevention Alarm/Sensor Attached Only

General Hospital

Rfid Chip For Dental Appliance

General Hospital

Bed, Manual

General Hospital

Indicator, Biological, Liquid Chemical Sterilization Process

General Hospital

Mid-Stream Collection Kit

General Hospital

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

General Hospital

Central Venous Catheter Dressing Change Kit

General Hospital

Bottle, Hot/Cold Water

General Hospital

Chamber, Reverse Isolation, Patient Care

General Hospital

Peripheral Catheter Insertion Kit

General Hospital

Kit, Chemical Snake-Bite

General Hospital

Body Temperature Sensing Software

General Hospital

Image Processing Device For Estimation Of External Blood Loss

General Hospital

Lubricant, Patient

General Hospital

Oral Lubricant

General Hospital

Implantable Radio Frequency Transponder System

General Hospital

Water, Vascular Access Flush

General Hospital

Buret Administration Intravenous Kit

General Hospital

Allergen And Vaccine Delivery Needles

General Hospital

Bed, Ac-Powered Adjustable Hospital

General Hospital

Mattress And Bed Deck Cover (Medical Purposes)

General Hospital

Unit, Neonatal Phototherapy

General Hospital

Infant Positioner, Rx, Use In Highly Monitored Setting

General Hospital