Product code MYF— Microbiology
SeraQuest HSV Type 2 Specific IgG
- Classification name
- Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code MYF
FDA has cleared devices under product code MYF between 2000 and 2025, filed by 8 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
- 2025
- 2022
- 2019
- 2018
- 2016
- 2011
- 2008
- 2007
- 2004
- 2000
Top applicants under product code MYF
Adverse events under product code MYF
product code MYF- Injury
- 316
- Other
- 1
- Total
- 317
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MYF
- K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
- K220924 — Elecsys HSV-2 IgG (08948887160)
- K181514 — SeraQuest HSV Type 2 Specific IgG
- K181334 — ADVIA Centaur Herpes-2 IgG
- K152353 — SeraQuest HSV Type 2 Specific IgG
- K103603 — ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
- K081687 — LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
- K061239 — EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT
- K033106 — CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT
- K993724 — HSV-2 ELISA IGG, MODEL EL0920G
Data sourced from openFDA. This site is unofficial and independent of the FDA.