VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210— 510(k) K993319

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code LGD

Device class

Class 2

Regulation

21 CFR 866.3780

Advisory panel

Microbiology

Date received

1999-10-04

Decision date

2000-05-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rockland, MA, US

• K242022 — Access Toxo IgG2025-03-28
• K242095 — Access Toxo IgM II2024-10-11
• K233932 — Alinity i Toxo IgM2024-08-30
• K210596 — ARCHITECT Toxo IgG2022-05-19
• K162678 — Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl2017-06-23

• K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System2026-07-08
• K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance2026-04-15
• K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)2025-08-21
• K234012 — VITEK COMPACT PRO2025-03-14
• K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)2024-06-12

Malfunction

502

Total

502

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 →