Gold Standard Diagnostics Corporation

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

Want to know more about this Organization? Request more information now!

Filters

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) (2) Reagents, Cysticercosis (MDJ) (2) Antisera, Cf, Influenza Virus A, B, C (GNW) (1) Antisera, Fluorescent, Brucella Spp. (GSM) (1) Antigens, Nontreponemal, All (GMQ) (1) Reagents, 2019-Novel Coronavirus Nucleic Acid (QJR) (1) Elisa, Trichinella Spiralis (MDT) (1) Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls (LJM) (1)

Premarket Exempt

No Yes

Clear

Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit - B350GSD0110300 Catalog Number : GSD01-1030

Device Description : Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative dete Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative detection of IgM 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 Anti-nuclear Antibody (ANA) Screening Test Kit - B350GSD0113000 Catalog Number :

Device Description : Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System - B350GSD0116000 Catalog Number :

Device Description : Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test Kit

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 1

GSD Toxocara canis IgG ELISA - B350GSD0130000 Catalog Number : GSD01-3000

Device Description : Toxocara canis IgG ELISA Test Kit

Device Class : 1

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : MDJ

Prescription Use : Yes

Device Count : 1

Toxocara canis IgG ELISA Test Kit - B350GSD0130010 Catalog Number : GSD01-3001

Device Description : Toxocara canis IgG ELISA Test Kit

Device Class : 1

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : MDJ

Prescription Use : No

Device Count : 1

Trichinella spiralis IgG ELISA Test Kit - B350GSD0130020 Catalog Number : GSD01-3002

Device Description : Trichinella spiralis IgG ELISA Test Kit

Device Class : 1

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : MDT

Prescription Use : No

Device Count : 1

GSD Brucella IgG ELISA - B350GSD0130070 Catalog Number : GSD01-3007

Device Description : Brucella IgG ELISA Test Kit

Device Class : 2

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : GSM

Prescription Use : Yes

Device Count : 1

Influenza B IgG ELISA Test Kit - B350GSD0130100 Catalog Number : GSD01-3010

Device Description : Gold Standard Diagnostics Influenza B IgG ELISA Test Kit

Device Class : 1

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : GNW

Prescription Use : No

Device Count : 1

Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk - B350GSD0410220 Catalog Number : GSD04-1022

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

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 - Bulk - B350GSD0410230 Catalog Number : GSD04-1023

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

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Previous 1 2 3 4 5 Next