QBQ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2560
- Medical specialty
- Microbiology
- FDA definition
- Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium
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| Record | Firm | Date |
|---|---|---|
| BacterioScan 216Dx System (K172412) | Bacterioscan, Inc. | 2018-05-01 |
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Every clearance here is in the API, with alerts when new ones post.