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Devices
Device Recall AmediCheck Instant Test Cup
Model / Serial
T0858
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide distribution in the states of: TN, NC, FL, and PA
Product Description
AmediCheck Instant Test Cup, Part No. C-C0501A-3A || Product Usage: || The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 300 ng/mL COC Amphetamine Amphetamine 1000 ng/mL AMP Methamphetamine Methamphetamine 1000 ng/mL MET Opiates Morphine 2000 ng/mL OPI Opiates300 Morphine 300 ng/ml OPI300 Phencyclidine Phencyclidine 25 ng/mL PCP Barbiturates Secobarbital 300 ng/mL BAR Benzodiazepines Oxazepam 300 ng/mL BZD Methadone Methadone 300 ng/mL MTD Oxycodone Oxycodone 100 ng/mL OXY MDMA MDMA 500 ng/mL MDMA Tricyclic Antidepressants Nortriptyline 1000 ng/mL TCA
Manufacturer
Branan Medical Corporation
1 Event
Recall of Device Recall AmediCheck Instant Test Cup
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Manufacturer
Branan Medical Corporation
Manufacturer Address
Branan Medical Corporation, 140 Technology Dr Ste 400, Irvine CA 92618-2426
Manufacturer Parent Company (2017)
Branan Medical Corporation
Source
USFDA
Language
English
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