VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II— 510(k) K141133
Substantially EquivalentBIOMERIEUX
FDA 510(k) clearance K141133 for VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II, Substantially Equivalent on 2015-07-09. Applicant: BIOMERIEUX. Device class: 1.
Clearance details
- Applicant
- BIOMERIEUX
- Product code
- Code LYR
- Device class
- Class 1
- Regulation
- 21 CFR 866.3110
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
Recent devices under product code LYR
view allMore clearances from BIOMERIEUX
view allAdverse events under product code LYR
product code LYR- Other
- 1
- Total
- 1
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 →
Recalls naming K141133
K-number listed on FDA's recall record- Z-0797-2023 — VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
- Z-0864-2023 — VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
- Z-0427-2022 — VIDAS DEX@, Dimer Exclusion II, REF 30455-01
- Z-0928-2020 — BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141133.
Data sourced from openFDA. This site is unofficial and independent of the FDA.