Gold Standard Diagnostics Corporation

Address:2795 2nd Street,Davis,CA,95618,US

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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

Reagent, Borrelia Serological Reagent (LSR) (6) Reagents, 2019-Novel Coronavirus Nucleic Acid (QJR) (2) General Purpose Reagent (PPM) (1) Reagents, Specific, Analyte (MVU) (1)

Premarket Exempt

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Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - B350GSD0110220 Catalog Number : GSD01-1022

Device Description : Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - B350GSD0110230 Catalog Number : GSD01-1023

Device Description : Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Borrelia burgodorferi IgG/IgM ELISA Test Kit - B350GSD0110240 Catalog Number : GSD10-1024

Device Description : Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit - B350GSD0110250 Catalog Number : GSD01-1025

Device Description : Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit - B350GSD0110260 Catalog Number : GSD01-1026

Device Description : Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit - B350GSD0110270 Catalog Number : GSD01-1027

Device Description : Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit - B350GSD0110280 Catalog Number : GSD01-1028

Device Description : Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit for the qualitative dete Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit for the qualitative detection of IgG antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).

Device Class :

Duns Number: 790524891

Premarket Exempt : No

Product Code : QJR

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit - B350GSD0110290 Catalog Number : GSD01-1029

Device Description : Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative dete Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).

Device Class :

Duns Number: 790524891

Premarket Exempt : No

Product Code : QJR

Prescription Use : Yes

Device Count : 1

SARS-CoV-2 Component Pack - B350GSD011029CP0 Catalog Number : GSD01-1029-CP

Device Description : SARS-CoV-2 Component Pack

Device Class : 1

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

SARS-CoV-2 IgA Sera Pack - B350GSD011029SP0 Catalog Number : GSD01-1029-SP

Device Description : SARS-CoV-2 IgA Sera PackAnalyte Specific Reagent

Device Class : 1

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

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