LGC

Product Code: LGC

Products Classified as LGC

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific

Herpes Simplex Virus Serological Assays.

Total Product Life Cycle (TPLC) Devices

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific

Herpes Simplex Virus Serological Assays.

Pre-market Notifications for LGC

K033059	HERPES GROUP IGG	TRINITY BIOTECH, INC.
K010878	MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6	DIAGNOSTIC PRODUCTS CORP.
K002262	DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM	DIAMEDIX CORP.
K000238	HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G	MRL DIAGNOSTICS
K992166	THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR	ZEUS SCIENTIFIC, INC.
K984346	PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST	MERIDIAN DIAGNOSTICS, INC.
K983886	POCKIT HSV 2 RAPID TEST	DIAGNOLOGY LTD.
K983656	HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM	ZEUS SCIENTIFIC, INC.
K983541	HSV 1+2 IGG ELISA TEST	GULL LABORATORIES, INC.
K981306	DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM	DIAMEDIX CORP.
K963645	HERPES GROUP IGG ELISA TEST SYSTEM	ARMKEL, LLC.
K963282	SERAQUEST HSV IGG	QUEST INTL., INC.
K953839	PREMIER HSV PLUS	MERIDIAN DIAGNOSTICS, INC.
K950670	IMMULITE HERPES I AND II IGG	DIAGNOSTIC PRODUCTS CORP.
K925208	ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION	ORTHO DIAGNOSTIC SYSTEMS, INC.

Global Unique Device Identification Database

00630414999784	Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific
00630414964171	Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific
00811727015211	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
00817273020174	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
00816057020577	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
00850487007333	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
00850487007142	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
00847865010740	Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific
05391516746496	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
05391516746489	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
05391516743709	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
20816101021004	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
00630414016726	Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific
B3507203500	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
B3507203400	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

Maude Adverse Events

BIOKIT HSV-2 RAPID TEST	BIOKIT, SA	2020-02-10
IMMULITE 2000 XPI - HVG	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED	2019-08-20
IMMULITE 2000 XPI - HVG	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED	2019-08-20
IMMULITE 2000 XPI - HVG	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED	2019-08-20
IMMULITE 2000 XPI - HVG	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED	2019-08-20
HERPESELECT ELISA		2014-01-29
IMMULITE 2000 HERPES I & II	SIEMENS HEALTHCARE DIAGNOSTICS	2012-09-27
HERPESELECT 1 AND 2 HSV IMMUNOBLOT	FOCUS DIAGNOSTICS, INC.	2007-12-21
HERPESELECT 1 AND 2 HSV IMMUNOBLOT	FOCUS DIAGNOSTICS, INC.	2007-12-17
HERPESELECT 1 AND 2 HSV IMMUNOBLOT	FOCUS DIAGNOSTICS, INC.	2007-12-17
HERPESELECT 1 AND 2 HSV IMMUNOBLOT	FOCUS DIAGNOSTICS, INC.	2007-12-17

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.