Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
The Enzyme Linked Immunosorbent Assay (ELISA) for Herpes Simplex Virus Type 2 (HSV-2) is an in vitro diagnostic test used to detect antibodies against HSV-2 in patient serum or plasma, supporting the serological diagnosis and type-specific differentiation of genital herpes. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 866.3305 (Microbiology specialty).
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Basic Information
- Product Code
- MYF
- Device Class
- FDA class 2
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | Feb 12, 2025 | Substantially Equivalent | Biokit, S.A. |
| K220924 | Elecsys HSV-2 IgG (08948887160) | Oct 12, 2022 | Substantially Equivalent | Roche Diagnostics |
| K181514 | SeraQuest HSV Type 2 Specific IgG | Jun 13, 2019 | Substantially Equivalent | Quest International, Inc. |
| K181334 | ADVIA Centaur Herpes-2 IgG | Aug 23, 2018 | Substantially Equivalent | Biokit, S.A. |
| K152353 | SeraQuest HSV Type 2 Specific IgG | May 13, 2016 | Substantially Equivalent | Quest International, Inc. |
| K103603 | ZEUS ELISA HSV GG-2 IGG TEST SYSTEM | May 20, 2011 | Substantially Equivalent | Zeus Scientific, Inc. |
| K081687 | LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG | Nov 10, 2008 | Substantially Equivalent | DiaSorin, Inc. |
| K061239 | EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT | Jun 28, 2007 | Substantially Equivalent | Euroimmun Us, LLC |
| K033106 | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT | Jul 13, 2004 | Substantially Equivalent | Trinity Biotech USA |
| K993724 | HSV-2 ELISA IGG, MODEL EL0920G | Feb 01, 2000 | Substantially Equivalent | Mrl Diagnostics |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.