Data / Medical devices / Brazil / bioBoaVista
bioBoaVista: FDA-registered device maker in Valinhos Sao Paulo, Brazil, 2 510(k) clearances
bioBoaVista is registered with the FDA (registration 3017830316) in Valinhos Sao Paulo, Brazil. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017830316
- Address
- Valinhos Sao Paulo, Brazil, 13273-200
- Owner or operator
- ALB LUZ (10079096)
- Roles
- Manufacturer
- First device listed
- November 18, 2020
- Registered through
- 2026
- Brand names listed
- Molecular Transport Media - MTM, Viral Transport Media (VTM), bioBoaVista, BBV
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Propagating Transport | JSM | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Selective And Non-Differential | JSG | 1 | Manufacturer | accessdata.fda.gov |
| Device, Specimen Collection | LIO | 1 | Manufacturer | accessdata.fda.gov |
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | 2 | Manufacturer | accessdata.fda.gov |
| Solution, Isotonic | JCE | 1 | Manufacturer | accessdata.fda.gov |
| Transport Medium, Notified Per The Vtm Guidance | QMC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 17, 2024 | K233324 | Molecular Transport Media - MTM | QBD | Substantially Equivalent | Alb Luz | accessdata.fda.gov |
| May 3, 2024 | K232454 | Viral Transport Media (VTM) | JSM | Substantially Equivalent | Alb Luz | accessdata.fda.gov |
Compare with other makers
- All makers of Culture Media, Non-Propagating Transport
- All makers of Solution, Isotonic
- All makers of Device, Specimen Collection
- All makers of Culture Media, Non-Selective And Non-Differential
- All makers of Microbial Nucleic Acid Storage And Stabilization Device
- All makers of Transport Medium, Notified Per The Vtm Guidance
Updated June 17, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.