International Medical Devices Database

Manufacturer Address
Branan Medical Corporation, 140 Technology Dr Ste 400, Irvine CA 92618-2426
Manufacturer Parent Company (2017)
Branan Medical Corporation
Source
USFDA
2 Events
- Recall of Device Recall ToxCup Drug Screen Cup
- Recall of Device Recall AmediCheck Instant Test Cup

2 devices in the database

Device Recall ToxCup Drug Screen Cup

Model / Serial
Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) and country of Canada.
Product Description
ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only.

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

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Branan Medical Corporation

2 devices in the database

Device Recall ToxCup Drug Screen Cup

Device Recall AmediCheck Instant Test Cup