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
FDA 510(k) clearance K141133 · decided 2015-07-09
Clearance details
- K-number
- K141133
- Device name
- 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
- Applicant
- BIOMERIEUX
- Decision
- Substantially Equivalent
- Date received
- 2014-05-01
- Decision date
- 2015-07-09
- Days to decision
- 434 days
- Clearance type
- Traditional
- Product code
- LYR
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Hazelwood, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226 recall (Z-0797-2023) | Biomerieux Inc | 2023-01-04 |
| VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01 recall (Z-0864-2023) | Biomerieux Inc | 2023-01-04 |