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Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
FDA product code MYF · Class 2 · Microbiology
32
Registered devices
337
Adverse events
2
Recalls
10
510(k) clearances
Devices with this code
Alinity — Abbott Ireland DiagnosticsAlinity — Abbott Ireland DiagnosticsHSV-2 ELISA IgG Conjugate — DIASORIN MOLECULAR LLCHSV-2 ELISA IgG Low Positive Control — DIASORIN MOLECULAR LLCHerpeSelect® 2 ELISA IgG — DIASORIN MOLECULAR LLCAlinity — Abbott Ireland DiagnosticsTrinity Biotech — CLARK LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.Anti-HSV-2 (gG2) ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AGElecsys HSV-2 IgG — Roche Diagnostics GmbHAccuDiag ™ — Diagnostic Automation, Inc.HSV-2 ELISA IgG High Positive Control — DIASORIN MOLECULAR LLCElecsys HSV-2 IgG — Roche Diagnostics GmbHBioPlex 2200 — BIO-RAD LABORATORIES, INC.LIAISON® HSV-2 Type Specific IgG — Diasorin Inc.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Elecsys HSV-2 IgG — Roche Diagnostics GmbHSeraQuest — QUEST INTERNATIONAL, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.HSV-2 IgG Antigen Wells — DIASORIN MOLECULAR LLCADVIA Centaur Herpes-2 IgG — Siemens Healthcare Diagnostics Inc.Trinity Biotech — CLARK LABORATORIES, INC.HerpeSelect® 2 ELISA IgG — DIASORIN MOLECULAR LLCBioPlex 2200 — BIO-RAD LABORATORIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-13 | Diasorin Inc. | DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAIS |
| 2021-02-08 | Siemens Healthcare Diagnostics, Inc | Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and |
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