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Company · US

Gold Standard Diagnostics

FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2025. Name variants (Inc, Corp, punctuation) are merged.

15510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
LSR	Reagent, Borrelia Serological Reagent	9
GMQ	Antigens, Nontreponemal, All	2
LYR	Helicobacter Pylori	2
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	1
MXJ	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Oct 10, 2025	K250249	Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System Gold Standard Diagnostics, LLC	GMQ
Mar 22, 2021	K203296	Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit Gold Standard Diagnostics	LSR
Mar 22, 2021	K203295	Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit Gold Standard Diagnostics	LSR
Mar 22, 2021	K203292	Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Gold Standard Diagnostics	LSR
Mar 22, 2021	K203289	Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit Gold Standard Diagnostics	LSR
Apr 6, 2020	K200025	Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit Gold Standard Diagnostics	LSR
Apr 6, 2020	K200023	Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit Gold Standard Diagnostics	LSR
May 2, 2018	K180264	Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Gold Standard Diagnostics	LSR
Nov 12, 2015	K150358	Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System Gold Standard Diagnostics	GMQ
Feb 28, 2014	K131334	HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST Gold Standard Diagnostics	MXJ
Jan 28, 2014	K131330	GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT Gold Standard Diagnostics	LJM
Jun 1, 2012	K113846	BORRELIA BURGDORFERI IGM BLOT TEST Gold Standard Diagnostics	LSR
Apr 11, 2012	K113847	BORRELIA BURGDORFERI IGG BLOT TEST Gold Standard Diagnostics	LSR
Mar 2, 2012	K110745	HELICOBACTER PYLORI ELISA IGG TEST KIT Gold Standard Diagnostics	LYR
Feb 1, 2012	K110899	GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT Gold Standard Diagnostics	LYR

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

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