DNA Genotek, Inc.
DNA Genotek, Inc. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2026, with 3 FDA device recalls on record.
Top product codes for DNA Genotek, Inc.
FDA recalls by DNA Genotek, Inc.
- Z-0982-2022 — ORAcollect RNA: ORE-100
- Z-0981-2022 — ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
- Z-3004-2020 — PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by DNA Genotek, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.