Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Microbiology · 21 CFR 866.3305
Recent MDR events
154 adverse event reports on file
- ALINITY I HSV-1 IGGMar 13, 2026MalfunctionAbbott Ireland Diagnostics Division3008344661-2026-00053
- HSV 1&2 TESTMar 26, 2025MalfunctionUnknownMW5168292
- ALINITY I HSV-1 IGG REAGENT KITMay 30, 2024MalfunctionAbbott Ireland Diagnostics Division3008344661-2024-00064
- HSV IGG 1Apr 26, 2024MalfunctionUnknownMW5154370
- HSV 1 IGG,TYPE SPECIFIC ABMar 27, 2024MalfunctionUnknownMW5153286
- DIASORIN LIASON XL HSV 1 AND 2 TYPE SPECIFIC ANTIBODY TESTJun 29, 2023InjuryDiasorin Inc.MW5118990
- DIASORIN LIASON XL HSV 1 AND 2 TYPE SPECIFIC ANTIBODY TESTJun 29, 2023InjuryDiasorin Inc.MW5118992
- DIASORIN LIASON XL HSV 1 AND 2 TYPE SPECIFIC ANTIBODY TESTJun 29, 2023InjuryDiasorin Inc.MW5118994
- DIASORIN LIASON XL HSV 1 AND 2 TYPE SPECIFIC ANTIBODY TESTJun 29, 2023InjuryDiasorin Inc.MW5118996
- DIASORIN LIASON XL HSV 1 AND 2 TYPE SPECIFIC ANTIBODY TESTJun 28, 2023InjuryDiasorin Inc.MW5118927
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
21 firms currently registered for this product code
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Zeus Scientific Llc
BRANCHBURG, NJ, US
Diasorin Molecular Llc
CYPRESS, CA, US
Trinity Biotech Usa
Jamestown, NY, US
Bio-rad Laboratories, Inc.
Hercules, CA, US
Bio-rad Laboratories, Inc.
Woodinville, WA, US
Abbott Laboratories
Lake Forest, IL, US
Drg International, Inc.
Springfield, NJ, US
Arlington Scientific, Inc.
SPRINGVILLE, UT, US
Monobind, Inc.
Lake Forest, CA, US
Diasorin Inc.
Stillwater, MN, US
Biokit S.a.
LLISSA D AMUNT Barcelona, ES
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Drg Instruments Gmbh
MARBURG Hesse, DE
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
510(k) clearances
20 clearances for this product code
- Biokit, S.A.Sep 20, 2023
K213987 · ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
- Roche DiagnosticsOct 12, 2022
K220923 · Elecsys HSV-1 IgG (08948844160)
- Biokit, S.A.Aug 23, 2018
K181333 · ADVIA Centaur Herpes-1 IgG
- Quest International, Inc.Oct 1, 2016
K162276 · SeraQuest Herpes Type 1 Specific IgG
- Theranos, Inc.Jul 2, 2015
K143236 · Theranos Herpes Simplex Virus-1 IgG Assay
- Gold Standard DiagnosticsFeb 28, 2014
K131334 · HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
- Roche DiagnosticsJul 25, 2012
K120625 · ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
- Bio-Rad LaboratoriesJun 22, 2012
K120959 · BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT