General Description
This product is designed for laboratory analysis. This product amplifies DNA or cDNA extracted from any sample.
Technical Description
This is a peltier-based system which amplifies DNA.
Notes:
Traditional themocycler not intended for real time analysis.
Evaluation Criteria
THROUGHPUT:
- Between 30 and 60 minutes for detection
- 95-32 samples every 2 hours
- The system could be adapted to a semi-automated system with some effort
- Device or system is intended for multiple detection assays
- 2 solutions, buffer, eluents, and/or reagents
- 2 components
- Less than 5 minutes is required for set-up
- 3-5 steps are required for detection
LOGISTICS:
- Very brief (minutes-hours) training and minimal technical skills
- Approximately the size of a toaster
- Between 5 and 25 kg
- Wired connections are available
- System or device has 110V electrical requirement
OPERATIONS:
- Can be used from 25°C to 37°C
- Components must be stored at room temperature (27°C)
- Device or system has peak performance at normal relative humidity conditions
- 5-10 years expected life
- Results cannot be viewed in real-time
- The system is not capable of autonomy
- The system software is closed and not available for modification
- The system hardware is closed and not available for modification
DETECTION:
- Not possible for the system to achieve 510K clearance
- Not possible for the system to achieve FDA approval
- Less than 50 µL
- Manual kit not integrated with the system handles spore lysis
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