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DNA Genotek Inc

Canada·CA-MF-000003486

Last updated May 30, 2026

Information

Country: Canada
Address: 3000 - 500, Palladium Drive, Ottawa, Canada
Website: www.dnagenotek.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 613 723 5757
PRRC Contact: Jonathan Chan
EUDAMED SRN: CA-MF-000003486
FDA FEI Number: —
DUNS Number: 207983508

Catalogue (38)

Device	Model / Reference	Registries	Class	Status
OMNIgene GUT Dx	OMD-200	FDA UDI	Class II	Active
ORAcollect Dx	OCD-100.014	FDA UDI	Class II	Active
Oragene Dx	OYD-500	FDA UDI	Class II	Unknown
Oragene Dx	OXD-500	FDA UDI	Class II	Active
ORAcollect RNA	ORE-100	EUDAMED	Class I	Active
PrepIT L2P	PT-L2P-45	EUDAMEDFDA UDI	Class A	Active
Oragene®•Dx	K192920	FDA 510(k)	Class II	Active
ORAcollect®•Dx	K212745	FDA 510(k)	Class II	Active
Colli-Pee® UCM® FV-5010	N00327	EUDAMEDFDA UDI	Class A	Active
ORAcollect Dx	OCD-100A	EUDAMEDFDA UDI	Class I	Active
ORAgene Dx	OGD-500.001	EUDAMEDFDA UDI	Class A	Active
ORAgene Dx	OGD-510	EUDAMEDFDA UDI	Class A	Active
Colli-Pee® UCM® FV-5004	N00260	EUDAMEDFDA UDI	Class A	Active
OMNIgene ORAL	OME-505.005	EUDAMEDFDA UDI	Class A	Active
Colli-Pee® UCM® FV-5020	N00176	EUDAMEDFDA UDI	Class A	Active
ORAgene Dx	OGD-675	EUDAMEDFDA UDI	Class A	Active
ORAgene DNA	OG-675	EUDAMED	Class A	Active
PrepIT L2P	PT-L2P-5	EUDAMEDFDA UDI	Class A	Active
OMNIgene GUT	OM-200	EUDAMEDFDA 510(k)	Class A	Active
Colli-Pee® FV-5010	N00309	EUDAMEDFDA UDI	Class A	Active
ORAgene DNA	OG-510	EUDAMED	Class A	Active
Colli-Pee® UAS® FV-5040	N00342	EUDAMEDFDA UDI	Class A	Active
Colli-Pee® FV-5020	N00055	EUDAMEDFDA UDI	Class A	Active
ORAgene Dx	OGD-575	EUDAMEDFDA UDI	Class A	Active
ORAgene ONE	ON-600	EUDAMED	Class A	Active
ORAgene DNA	OG-610	EUDAMED	Class A	Active
ORAcollect DNA	OCR-100	EUDAMED	Class I	Active
OMNIgene Liquefaction Reagent	OM-LQR-400	EUDAMEDFDA UDI	Class A	Active
ORAgene Dx	OGD-610	EUDAMEDFDA UDI	Class A	Active
Og-Ac1	OG-AC1	EUDAMEDFDA UDI	Class I	Active
Colli-Pee® FV-5004	N00290	EUDAMEDFDA UDI	Class A	Active
ORAgene Dx	OGD-500	EUDAMEDFDA UDI	Class A	Active
ORAgene Dx	OGD-600	EUDAMEDFDA UDI	Class A	Active
Colli-Pee® UCM® FV-5003b	N00383	EUDAMEDFDA UDI	Class A	Active
OMNIgene Liquefaction Reagent	OM-LQR-1600	EUDAMEDFDA UDI	Class A	Active
ORAcollect Dx	OCD-100	EUDAMEDFDA UDI	Class I	Active
Colli-Pee® FV-5040	N00269	EUDAMEDFDA UDI	Class A	Active
Colli-Pee® FV-5020c	N00238	EUDAMEDFDA UDI	Class A	Active

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