QVB — Biological Sterilization Indicator With Indirect Growth Detection Class II
Classification Details
- Product Code
- QVB
- Device Class
- Class II
- Regulation Number
- 880.2806
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
A biological sterilization indicator with indirect growth detection capabilities is a device intended for use by a healthcare provider to accompany products being sterilized through a sterilization process to monitor the adequacy of sterilization. Detection of surviving microorganisms is accomplished by a method other than direct detection of growth or growth products.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220042 | terragene | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon | July 12, 2024 |