Is this your brand? Sign in to claim ownership.

BIOLYTICAL LABORATORIES INC.

Canada·CA-MF-000023304

Last updated September 17, 2026

Information

Country: Canada
Address: 406-13251 Delf Place, Richmond, Canada
Website: biolytical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +16042046784 ext 262
PRRC Contact: Ana Subramanian
EUDAMED SRN: CA-MF-000023304
FDA FEI Number: 3003871407
DUNS Number: —

Catalogue (43)

Device	Model / Reference	Registries	Class	Status
Insti Hiv Antibody Self-Test	90-1076-003 and 90-1076-004	EUDAMED	IVD Annex II List A	Active
Insti Hcv Antibody Test	90-1062-001, 90-1062-002, and 90-1062-003	EUDAMED	IVD Annex II List A	Active
INSTI HCV Test Controls	90-1067	EUDAMED	IVD Annex II List A	Active
INSTI HIV-1/HIV-2 Control Test Kit	90-1031	FDA UDI	Class II	Active
INSTI HIV-1/HIV-2 Antibody Test	Without Support	FDA UDI	Class II	Unknown
INSTI HIV-1 Control Test Kit	90-1030	FDA UDI	Class II	Unknown
HIV-1 Control Test Kit	90-1030	FDA UDI	Class II	Unknown
INSTI HIV-1/HIV-2 Antibody Test	90-1019	FDA UDI	Class II	Active
INSTI HIV-1/HIV-2 Control Test	90-1031	FDA UDI	Class II	Unknown
INSTI HIV-1/HIV-2 Antibody Test	Single	FDA UDI	Class II	Unknown
INSTI HIV-1/HIV-2 Test Controls	80-1037	FDA UDI	Class II	Active
INSTI HIV-1/HIV-2 Antibody Test	With Support	FDA UDI	Class II	Active
INSTI Test Controls HIV-1	80-1071	FDA UDI	Class II	Unknown
Insti Hiv Antibody Self-Test	90-1058-001 and 90-1058-002	EUDAMED	IVD Annex II List A	Active
INSTI Multiplex HIV-1/2 Syphilis Ab Test	90-1028-017 and 90-1028-018	EUDAMED	IVD Annex II List A	Active
INSTI HIV Self Test (no pipette variant, packaged in a pouch)	90-1041-007	EUDAMED	IVD Annex II List A	Active
Insti Hiv-1/Hiv-2 Antibody Test Kit	90-1015-010	EUDAMED	IVD Annex II List A	Active
Insti Hiv Antibody Self-Test	90-1059-001 and 90-1059-002	EUDAMED	IVD Annex II List A	Active
INSTI Multiplex HIV-1/2 Syphilis Ab Test	90-1028-001 and 90-1028-002	EUDAMED	IVD Annex II List A	Active
48 Insti Hiv-1/Hiv-2 Antibody Test	90-1026-001	EUDAMED	IVD Annex II List A	Active
Insti Hiv Antibody Self-Test	90-1063	EUDAMED	IVD Annex II List A	Active
INSTI HIV Self Test (no pipette variant, packaged in a pouch)	90-1041-001 and 90-1041-002	EUDAMED	IVD Annex II List A	Active
INSTI HIV Self Test (no pipette variant, packaged in pouch)	90-1041-012 and 90-1041-013	EUDAMED	IVD Annex II List A	Active
INSTI Multiplex HIV-1/2 Syphilis Ab Test	90-1028-021 and 90-1028-022	EUDAMED	IVD Annex II List A	Active
Insti Hiv-1/Hiv-2 Antibody Test	90-1015-003 and 90-1015-004	EUDAMED	IVD Annex II List A	Active
Insti Hiv Antibody Self-Test	90-1060-001, 90-1060-002, 90-1060-003 and 90-1060-004	EUDAMED	IVD Annex II List A	Active
INSïl HIV Self Test (no pipette variant, packaged in a box)	90-1057-001 and 90-1057-002	EUDAMED	IVD Annex II List A	Active
48 Insti Hiv-1/Hiv-2 Antibody Test	90-1026-002	EUDAMED	IVD Annex II List A	Active
Insti Hiv-1/Hiv-2 Antibody Test	90-1015-011 and 90-1015-012	EUDAMED	IVD Annex II List A	Active
Insti Hiv-1/Hiv-2 Antibody Test Kit	90-1026	EUDAMED	IVD Annex II List A	Active
Insti Hiv-1/Hiv-2 Antibody Test	90-1015-001 and 90-1015-002	EUDAMED	IVD Annex II List A	Active
INSTI Multiplex HIV-1/2 Syphilis Ab Test	90-1028-009	EUDAMED	IVD Annex II List A	Active
Insti Hiv-1/Hiv-2 Antibody Test	90-1015-008	EUDAMED	IVD Annex II List A	Active
Insti Hiv Antibody Self-Test	90-1050	EUDAMED	IVD Annex II List A	Active
INSTI Multiplex HIV-1/2 Syphilis Ab Test	90-1028-015 and 90-1028-016	EUDAMED	IVD Annex II List A	Active
Insti Hiv-1/Hiv-2 Antibody Test	90-1015-009	EUDAMED	IVD Annex II List A	Active
Insti Hiv-1/Hiv-2 Antibody Test	90-1015-013 and 90-1015-014	EUDAMED	IVD Annex II List A	Active
INSïl HIV Self Test (no pipette variant, packaged in a box)	90-1056-001 and 90-1056-002	EUDAMED	IVD Annex II List A	Active
INSTI HIV-1/HIV-2 Test Controls	90-1036	EUDAMED	IVD Annex II List A	Active
INSTI T. pallidum Test Controls	90-1032	EUDAMED	IVD Annex II List A	Active
Insti Hiv-1/Hiv-2 Antibody Test Kit	90-1015-017 and 90-1015-018	EUDAMED	IVD Annex II List A	Active
Insti Hiv Antibody Self-Test	90-1058	EUDAMED	IVD Annex II List A	Active
INSTI Multiplex HIV-1/2 Syphilis Ab Test	90-1028-008	EUDAMED	IVD Annex II List A	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL
Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.