VIDAS RUB IGG— 510(k) K080766

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code LFX

Device class

Class 2

Regulation

21 CFR 866.3510

Advisory panel

Microbiology

Date received

2008-03-18

Decision date

2008-12-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hazelwood, MO, US

• K250588 — Access Rubella IgG2025-11-17
• K243168 — Alinity i Rubella IgG2025-06-20
• K122397 — LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM2012-09-06
• K093101 — MAGO 4S2011-01-21
• K092587 — BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM2010-12-03

• 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