Quidel Molecular RSV + HMPV Assay
FDA 510(k) K131813 · Quidel Corp.
510(k) numberK131813
Submission
- Device name
- Quidel Molecular RSV + HMPV Assay
- Applicant
- Quidel Corp.
San Diego, CA, US - Received
- June 20, 2013
- Decision date
- September 6, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCC – Respiratory Virus Panel Nucleic Acid Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of…
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Questions and answers
When was Quidel Molecular RSV + HMPV Assay cleared by the FDA?
Quidel Molecular RSV + HMPV Assay (K131813) received a 510(k) decision of Substantially Equivalent on September 6, 2013, 78 days after the submission was received.
What is the product code of K131813?
The FDA product code is OCC – Respiratory Virus Panel Nucleic Acid Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.