FDA Registration
Active
🇧🇷 Brazil
bioBoaVista
Reg #: 3017830316
·
FEI: 3017830316
·
Expires 2026
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
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Registration Details
- Registration Name
- bioBoaVista
- Registration Number
- 3017830316
- FEI Number
- 3017830316
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- [email protected]
- City
- Valinhos Sao Paulo
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K232454
Owner / Operator
- Firm Name
- ALB LUZ
- Operator Number
- 10079096
- Address
- Rua Um, 437
- City
- Valinhos
- State
- Sao Paulo
- Postal Code
- 13273-200
- Country
- BR
- Correspondent
- Ana Luiza Bueno Luz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Specimen Collection | LIO | Class 1 | Microbiology | No | 2020-11-18 |
| Transport Medium, Notified Per The Vtm Guidance | QMC | Class 1 | Microbiology | No | 2021-03-15 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2021-02-23 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2024-05-15 |
| Solution, Isotonic | JCE | Class 1 | Pathology | No | 2021-01-20 |
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | Class 2 | Microbiology | No | 2024-07-26 |
| Culture Media, Non-Selective And Non-Differential | JSG | Class 1 | Microbiology | No | 2021-03-15 |
Proprietary Names
bioBoaVista, BBV
Molecular Transport Media - MTM
Viral Transport Media (VTM)
Establishment Types
Manufacture Medical Device