CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT— 510(k) K033106

Name: FDA 510(k) clearance K033106
Creator: U.S. Food and Drug Administration
Published: 2004-07-13

Substantially Equivalent

Trinity Biotech USA

FDA 510(k) clearance K033106 for CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT, Substantially Equivalent on 2004-07-13. Applicant: Trinity Biotech USA. Device class: 2.

Clearance details

Applicant: Trinity Biotech USA
Product code: Code MYF
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2003-09-30
Decision date: 2004-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamestown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MYF

view all

K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls2025-02-12
K220924 — Elecsys HSV-2 IgG (08948887160)2022-10-12
K181514 — SeraQuest HSV Type 2 Specific IgG2019-06-13
K181334 — ADVIA Centaur Herpes-2 IgG2018-08-23
K152353 — SeraQuest HSV Type 2 Specific IgG2016-05-13

More clearances from Trinity Biotech USA

view all

K140455 — CAPTIA MEASLES IGM2014-05-22
K033105 — CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT2004-07-13
K033051 — LEGIONELLA PNEUMOPHILA IGG/IGM2003-11-26
K033064 — MYCOPLASMA IGG2003-11-26
K033067 — PYLORI IGG2003-11-26

Adverse events under product code MYF

product code MYF

Injury: 316
Other: 1
Total: 317

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.