Rapid-Exams, Inc. and Branan Medical Corporation are very pleased to announce that the FDA has approved the new Oratect® Oral Fluid Drug Screen Device test as an in vitro diagnostic testing device.
The new Branan Medical Corporation Oratect® is the first and only on-site saliva test to be FDA approved. The FDA stated that, “all Oral Fluid Drug Screen Devices require pre-market clearance from FDA before they can be sold”. This means that the new Branan Medical Oratect® is the only on-site saliva drug test that can be used for on-site, Point of Care testing. All other devices that do not have FDA approval will no longer be allowed.
The new FDA approved Oratect® HM15 replaces the former Oratect III HM11 for sale in the United States. The new Oratect® looks similar to the previous device known as the HM11 and the testing procedures are the same. However, the cutoff levels required by FDA for the new HM15 will be different for some drugs. The cutoff levels for the new Oratect® will be as follows:
To take advantage of the first FDA approved Oral Fluid Drug Screen Device, contact our CSR at (877.747.TEST ext. 2) your authorized Branan Medical Corporation distributor right away for bulk pricing or bulk discounts.
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