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

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (4) Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific (LGC) (2) Antigens, Nontreponemal, All (GMQ) (1) Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (LFZ) (1) Enzyme Linked Immunoabsorbent Assay, Rubella (LFX) (1) Extractable Antinuclear Antibody, Antigen And Control (LLL) (1)

Premarket Exempt

No Yes

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ThunderBolt EIA - B350003000 Catalog Number : 00300

Device Class : 1

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : No

Device Count : 1

ThunderBolt EIA (CLIA) - B35000300CL0 Catalog Number : 00300CL

Device Description : ThunderBolt EIA-CLIA

Device Class : 1

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : No

Device Count : 1

AIX1000 Analyzer - B350004000 Catalog Number :

Device Description : AIX1000 Rapid Plasma Reagin (RPR) Analyzer

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 1

Bolt - B350005000 Catalog Number : 00500

Device Description : Bolt EIA

Device Class : 1

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : No

Device Count : 1

Bolt (CLIA) - B35000500CL0 Catalog Number : 00500CL

Device Description : Bolt EIA-CLIA

Device Class : 1

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : No

Device Count : 1

Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit - B3507202800 Catalog Number : 720-280

Device Description : ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies against Scl-70 in human serum as an aid in the diagnosis of autoimmune disease.

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LLL

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit - B3507203200 Catalog Number : 720-320

Device Description : ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytome ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytomegalovirus (CMV) as an aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals.

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LFZ

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit - B3507203400 Catalog Number : 720-340

Device Description : ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to he ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV.

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LGC

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit - B3507203500 Catalog Number : 720-350

Device Description : ImmunoSimplicity (Is) HSV 1&2 IgM Test for the detection of IgM antibodies to he ImmunoSimplicity (Is) HSV 1&2 IgM Test for the detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV.

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LGC

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit - B3507203600 Catalog Number : 720-360

Device Description : ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-qu ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-quantitative detection of IgG antibodies to rubella in human serum to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child bearing age.

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LFX

Prescription Use : Yes

Device Count : 1

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