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) (2) Helicobacter Pylori (LYR) (2) Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster (LFY) (1) Epstein-Barr Virus, Other (LSE) (1) General Purpose Reagent (PPM) (1) Enzyme Linked Immunoabsorbent Assay, Mumps Virus (LJY) (1) Reagents, Specific, Analyte (MVU) (1) Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (LJB) (1)

Premarket Exempt

No Yes

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Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit - B3507203800 Catalog Number : 720-380

Device Description : ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitat ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitative and semi-quantitative detection of IgG antibodies to VZV to determine a prior exposure to VZV and to aid in the determination of acute or convalescent stage of VZV infection.

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LFY

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit - B3507205200 Catalog Number : 720-520

Device Description : ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to me ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to measles virus as an aid in the assessment of the patient's immunological response to measles and to determine the immune status of individuals, and as an aid in the diagnosis of measles infection.

Device Class : 1

Duns Number: 790524891

Premarket Exempt : No

Product Code : LJB

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit - B3507205400 Catalog Number : 720-540

Device Description : ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-q ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-quantitative determination of IgG antibodies to Mumps virus in human serum of adults over eighteen years of age by indirect enzyme immunoassay as an aid in the diagnosis of Mimps infection.

Device Class : 1

Duns Number: 790524891

Premarket Exempt : No

Product Code : LJY

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit - B3507206300 Catalog Number : 720-630

Device Description : ImmunoSimplicity (Is) EBNA-1 IgM ELISA Test Kit for the qualitative determinatio ImmunoSimplicity (Is) EBNA-1 IgM ELISA Test Kit for the qualitative determination of IgM antibodies to Epstein-Bar Virus Nuclear Antigen-1 (EBNA-1 IgM) in human serum by indirect enzyme immunoassay.

Device Class : 1

Duns Number: 790524891

Premarket Exempt : No

Product Code : LSE

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics H. pylori ELISA IgG Test Kit - B350GSD0110000 Catalog Number :

Device Description : Gold Standard Diagnostics Helicobacter pylori IgG ELISA Test Kit

Device Class : 1

Duns Number: 790524891

Premarket Exempt : No

Product Code : LYR

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics H. pylori ELISA IgA Test Kit - B350GSD0110010 Catalog Number :

Device Description : Gold Standard Diagnostics H. pylori ELISA IgA Test Kit

Device Class : 1

Duns Number: 790524891

Premarket Exempt : No

Product Code : LYR

Prescription Use : Yes

Device Count : 1

H. pylori IgM Sera Pack - B350GSD011002CP0 Catalog Number : GSD01-1002-CP

Device Description : H. pylori IgM Sera Pack

Device Class : 1

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

H. pylori Component Pack - B350GSD011002HCP0 Catalog Number : GSD01-1002-HCP

Device Description : H. pylori Component Pack

Device Class : 1

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - B350GSD0110180 Catalog Number : GSD01-1018

Device Description : Gold Standard Diagnostics Borrelia burgodorferi 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 - B350GSD0110190 Catalog Number : GSD01-1019

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

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