HSV-2 Elisa Igg, Model EL0920G
FDA 510(k) K993724 · Mrl Diagnostics
510(k) numberK993724
Submission
- Device name
- HSV-2 Elisa Igg, Model EL0920G
- Applicant
- Mrl Diagnostics
Cypress, CA, US - Received
- November 3, 1999
- Decision date
- February 1, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MYF – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code MYF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsMYF · Traditional | Biokit, S.A. | 02/12/2025SE |
| K220924 | Elecsys HSV-2 IgG (08948887160)MYF · Traditional | Roche Diagnostics | 10/12/2022SE |
| K181514 | SeraQuest HSV Type 2 Specific IgGMYF · Traditional | Quest International, Inc. | 06/13/2019SE |
| K181334 | ADVIA Centaur Herpes-2 IgGMYF · Traditional | Biokit, S.A. | 08/23/2018SE |
| K152353 | SeraQuest HSV Type 2 Specific IgGMYF · Traditional | Quest International, Inc. | 05/13/2016SE |
| K103603 | Zeus Elisa HSV GG-2 Igg Test SystemMYF · Traditional | Zeus Scientific, Inc. | 05/20/2011SE |
| K081687 | Liaison HSV-2 Type Specific Igg Assay, Control HSV-2 IggMYF · Traditional | DiaSorin, Inc. | 11/10/2008SE |
| K061239 | Euroimmun ANTI-HSV-2 Elisa (Igg) and ANTI-HSV-1 Elisa (Igg) KitMYF · Traditional | Euroimmun Us, LLC | 06/28/2007SE |
| K033106 | Captia HSV 2 Igg Type Specific Elisa KitMYF · Traditional | Trinity Biotech USA | 07/13/2004SE |
More from Trinity Biotech USA
| 510(k) | Device | Decision |
|---|---|---|
| K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GLGC · Traditional | 04/14/2000SE |
| K993754 | HSV-1 Elisa Igg, Model EL0910GMXJ · Traditional | 02/09/2000SE |
| K971007 | Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M)LSR · Traditional | 06/01/1998SE |
| K971006 | Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (WB0400G)LSR · Traditional | 06/01/1998SE |
| K946353 | Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent AssayLLM · Traditional | 07/21/1995SE |
| K931520 | Epstein-Barr Virus Vca (Igm) Recomb Immun AntibodyLJN · Traditional | 04/26/1994SE |
Questions and answers
When was HSV-2 Elisa Igg, Model EL0920G cleared by the FDA?
HSV-2 Elisa Igg, Model EL0920G (K993724) received a 510(k) decision of Substantially Equivalent on February 1, 2000, 90 days after the submission was received.
What is the product code of K993724?
The FDA product code is MYF – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.