Branan Medical Corporation is very pleased to announce that the United States Food and Drug Administration (FDA) has cleared the new Oratect® Oral Fluid Drug Screen device as an in vitro diagnostic
testing device. HM15 aka HM-11 Oratect III.
Branan Medical Corporation Oratect® is the first and only on-site Oral Fluid test to be FDA cleared 510(k) for use at point-of-care sites
. The FDA stated that all Oral Fluid drug test screen tests require premarket clearance from the FDA before they can be sold. This means that the new Branan Medical Oratect® is the only on-site Oral Fluid Drug Screen test that can be used for Point-of-Care testing. All other devices that do not have FDA clearance will no longer be allowed.
The new FDA cleared Oratect® Oral Fluid product catalog number is HM15 and will detect THC, Cocaine, Opiates, Amphetamine, Methamphetamine/ MDMA, and PCP.
The Oratect HM-15 Oral Fluid Drug Screen Device has a blue line indicator for the sufficient collection of saliva. Oratect is the only one-step chromatographic immunoassay device for the qualitative detection of marijuana (THC), cocaine, amphetamine, opiate, methamphetamine including MDMA (Ecstasy) and phencyclidine in oral fluid. The presence or absence of a red line corresponding to a specific drug on the panel indicates a negative result or presumptive positive result respectively. Oratect is now an IVD (in vitro diagnostic) Oral Fluid Drug Test Screen 6 Panel. This onsite saliva screen allows testers to obtain the rapid results they need without having the concerns of handling a urine specimen. $318.75 per box of 25
Oratect HM15 FDA Approved oral drug test panel, Oratect III is an oral fluid drug screen. 6 panel oral fluid drug testing, saliva oral fluid drug screening device.