Visby Medical Respiratory Health Test
Visby Medical, Inc. · Microbiology
Open FDA's page for this record- Third party flag
- N
- City
- San Jose
- Advisory committee description
- Microbiology
- Address 1
- 3010 N. First St.
- Statement or summary
- Summary
- Product code
- QOF
- Zip code
- 95134
- Applicant
- Visby Medical, Inc.
- Decision date
- 2025-02-19
- Decision code
- SESE
- Country code
- US
- Device name
- Visby Medical Respiratory Health Test
- Advisory committee
- MI
- Contact
- Jennifer Albrecht
- K number
- K242526
- State
- CA
- Date received
- 2024-08-26
- Review advisory committee
- MI
- Postal code
- 95134
- Decision description
- Substantially Equivalent
- Clearance type
- Dual Track
- Harmonized identifiers (openFDA)
- Device name
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Medical specialty description
- Microbiology
- Regulation number
- 866.3981
- Device class
- 2
- Registration number
- 3009976420, 1528450, 3014515702, 3014654360, 2024800, 3007420875, 2243471, 3003795116, 3016838963, 3044563551, 3009613136, 3006247421, 3009302820, 3002773840, 2023365, 3021140368, 3035381641, 3004530258, 3014553740, 3004141078, 3023999024, 3011104381, 3006028115, 3004013603, 1119779, 3011057574, 3002777243, 3044741637, 3005248192, 3019837962, 3011240982, 3008632402, 3010770794
- FEI number
- 3009976420, 3014515702, 3014654360, 2024800, 3007420875, 2243471, 3003795116, 3016838963, 3044563551, 3009613136, 3006247421, 3009302820, 3002773840, 2023365, 3021140368, 3035381641, 3004530258, 3014553740, 3004141078, 3023999024, 3011104381, 3006028115, 3004013603, 1119779, 3011057574, 3002777243, 3044741637, 3005248192, 3019837962, 3011240982, 3008632402, 3010770794, 1000122536