Biolytical Laboratories Inc

Address:406 - 13251 Delf Place,Richmond British Columbia,CA

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Test, Hiv Detection (MZF) (10)

Premarket Exempt

Clear

INSTI HIV-1/HIV-2 Antibody Test - 00686597010198 Catalog Number : 90-1019

Device Description : Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)

Device Class : 2

Duns Number: 201060071

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

INSTI HIV-1 Control Test Kit - 00686597010303 Catalog Number : 90-1030

Device Description : INSTI HIV-1 Control Test Kit

Device Class : 2

Duns Number: 201060071

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

INSTI HIV-1/HIV-2 Control Test Kit - 00686597010310 Catalog Number : 90-1031

Device Description : INSTI HIV-1/HIV-2 Control Test Kit

Device Class : 2

Duns Number: 201060071

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

INSTI HIV-1/HIV-2 Test Controls - 06865978010376 Catalog Number : 80-1037

Device Description : INSTI HIV-1/HIV-2 Test Controls

Device Class : 2

Duns Number: 201060071

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

INSTI Test Controls HIV-1 - 06865978010710 Catalog Number : 80-1071

Device Description : INSTI Test Controls HIV-1

Device Class : 2

Duns Number: 201060071

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

INSTI HIV-1/HIV-2 Antibody Test - 06865979010184 Catalog Number : 90-1018

Device Description : 24 Tests with support materials

Device Class : 2

Duns Number: 201060071

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

INSTI HIV-1/HIV-2 Antibody Test - 06865979010191 Catalog Number : 90-1019

Device Class : 2

Duns Number: 201060071

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

INSTI HIV-1/HIV-2 Antibody Test - 06865979010207 Catalog Number : 90-1020

Device Description : 24 tests without support material

Device Class : 2

Duns Number: 201060071

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

HIV-1 Control Test Kit - 06865979010306 Catalog Number : 90-1030

Device Description : HIV-1 Control Test Kit

Device Class : 2

Duns Number: 201060071

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

INSTI HIV-1/HIV-2 Control Test - 06865979010313 Catalog Number : 90-1031

Device Description : INSTI HIV-1/HIV-2 Control Test

Device Class : 2

Duns Number: 201060071

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

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