Rotor-Gene Q MDX
FDA 510(k) K113319 · QIAGEN GmbH
510(k) numberK113319
Submission
- Device name
- Rotor-Gene Q MDX
- Applicant
- QIAGEN GmbH
Gaithersburg, MD, US - Received
- November 10, 2011
- Decision date
- February 6, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OOI – Real Time Nucleic Acid Amplification System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.2570
- Specialty
- Clinical Chemistry
The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated…
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Questions and answers
When was Rotor-Gene Q MDX cleared by the FDA?
Rotor-Gene Q MDX (K113319) received a 510(k) decision of Substantially Equivalent on February 6, 2012, 88 days after the submission was received.
What is the product code of K113319?
The FDA product code is OOI – Real Time Nucleic Acid Amplification System, a Class II (moderate risk) device regulated under 21 CFR 862.2570.