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.
The
new 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.
