Gold Standard Diagnostics Corporation

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

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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) (4) Antigens, Nontreponemal, All (GMQ) (1) General Purpose Reagent (PPM) (1) Reagents, Specific, Analyte (MVU) (1)

Premarket Exempt

No Yes

Clear

HHV-6 IgG Plates - Bulk - B350GSD051700AW0 Catalog Number : GSD05-1700-AW

Device Description : HHV-6 IgG Plates - Bulk

Device Class : 1

Duns Number: 790524891

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

IgG Component Pack - Bulk - B350GSD051700CP0 Catalog Number : GSD05-1700-CP

Device Description : IgG Component Pack - Bulk

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 - B350GSD0610180 Catalog Number :

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

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Borrelia burgodorferi B31 IgM Line Blot Test Kit - B350GSD0610190 Catalog Number :

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

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - B350GSD1010220 Catalog Number : GSD10-1022

Device Description : Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - 10 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 - B350GSD1010230 Catalog Number : GSD10-1023

Device Description : Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - 10 Pack

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Microtiterplates - B350GSD1600WCASE0 Catalog Number : GSD-1600-W-CASE

Device Description : Microtiterplates 48-well microtiter plates - bulk

Device Class : 2

Duns Number: 790524891

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 1

Gold Standard Diagnostics RPR Reagent Pack - B350GSD341600R0 Catalog Number : GSD34-1600-R

Device Description : Rapid Plasma Reagin (RPR) Reagent Pack

Device Class :

Duns Number: 790524891

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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