Dna Specimen Collection, Saliva
Clinical Chemistry · 21 CFR 862.1675
A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.
Recent MDR events
4 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Registered firms
35 firms currently registered for this product code
Labcorp Genetics
San Francisco, CA, US
Orasure Technologies Inc.
BETHLEHEM, PA, US
Orasure Technologies, Inc.
Bethlehem, PA, US
Dna Genotek, Inc.
Ottawa Ontario, CA
Southmedic, Inc.
BARRIE Ontario, CA
Privapath Diagnostics Ltd
Dublin 11, IE
L-d Tool & Die Division Of Madix Engineering
Ottawa Ontario, CA
Autogenomics, Incorporated
Carlsbad, CA, US
Service Graphics, Inc.
INDIANAPOLIS, IN, US
Alom Technologies Corporation
FREMONT, CA, US
Integra Biotechnical, Sa De Cv
Tijuana Baja California, MX
Color Diagnostics, Llc
South San Francisco, CA, US
510(k) clearances
7 clearances for this product code
- DNA Genotek, Inc.Oct 27, 2022
K212745 · ORAcollect®Dx
- Ancestry Genomics, Inc.Aug 13, 2020
K192947 · AncestryDNA Saliva Collection Kit
- DNA Genotek, Inc.Jan 14, 2020
K192920 · Oragene®Dx
- DNA Genotek, Inc.May 26, 2016
K152464 · ORAcollect.Dx
- DNA Genotek, Inc.May 26, 2016
K152556 · Oragene Dx
- DNA Genotek, Inc.Feb 19, 2015
K141410 · ORAGENE DX OGD-500.001
- DNA Genotek, Inc.Dec 2, 2011
K110701 · ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500