Product code LGC— Microbiology
ABBOTT HSV EIA
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Total cleared
- 38
- First cleared
- Most recent
Market context for product code LGC
FDA has cleared devices under product code LGC between 1981 and 2003, filed by 21 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2003
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
- 1992
- 1991
- 1990
- 1989
- 1985
- 1984
- 1983
- 1981
Top applicants under product code LGC
Recent clearances under product code LGC
- K033059 — HERPES GROUP IGG
- K010878 — MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
- K002262 — DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
- K000238 — HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
- K992166 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K983886 — POCKIT HSV 2 RAPID TEST
- K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
- K983656 — HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
- K983541 — HSV 1+2 IGG ELISA TEST
- K981306 — DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
- K963645 — HERPES GROUP IGG ELISA TEST SYSTEM
- K963282 — SERAQUEST HSV IGG
- K950670 — IMMULITE HERPES I AND II IGG
- K953839 — PREMIER HSV PLUS
- K925208 — ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION
- K922333 — BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA
- K922334 — BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA
- K922758 — HSV-1 IGM ELISA TEST -- MODIFICATION
- K922759 — HSV-2 IGM ELISA TEST--MODIFICATION
- K922583 — BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA
- K922584 — BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA
- K915551 — ORTHO HSV ANTIGEN ELISA TEST
- K910952 — HSV-2 IGG ELISA TEST
- K910953 — HSV-2 IGM ELISA TEST
- K910954 — HSV-1 IGG ELISA TEST
- K910955 — HSV-1 IGM ELISA TEST
- K910499 — IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
- K903926 — KODAK SURECELL HERPES (HSV) CONTROL FLUID SET
- K903070 — SEROCARD HSV IGG ANTIBODY TEST KIT
- K900713 — HERPTRAN CONCENTRATE
- K871877 — IDEIA HERPES SIMPLEX VIRUS TEST
- K884246 — MODIFIED DDI SEROCARD HERPES IGG TEST KIT
- K884680 — KODAK SURECELL HERPES (HSV) TEST KIT
- K843077 — ELISA FOR HERPES SIMPLEX VIRUS
- K843622 — ABBOTT HSV EIA
- K834449 — HSV ANTIGEN ELISA KIT
- K822883 — HERPELISA KIT
- K802526 — TEST KIT FOR DETECTION OF HERPES SIMPLEX
Data sourced from openFDA. This site is unofficial and independent of the FDA.