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510(k) K122189

QUIDEL MOLECULAR RSV + HMPV ASSAY by Quidel Corp. — Product Code OEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2013
Date Received
July 24, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Human Metapneumovirus (Hmpv) Rna Assay System
Device Class
Class II
Regulation Number
866.3980
Review Panel
MI
Submission Type

A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infections.

Other clearances by Quidel Corp.

  • K131813 — QUIDEL MOLECULAR RSV + HMPV ASSAY (September 6, 2013)
  • K131728 — QUIDEL MOLECULAR INFLUENZA A + B ASSAY (August 29, 2013)
  • K130398 — SOFIA(R) RSV FIA (August 13, 2013)
  • K131166 — SOFIA(R) HCG FIA (August 2, 2013)
  • K131606 — SOFIA INFLUENZA A+B FIA (July 5, 2013)
  • K131619 — QUICKVUE INFLUENZA A+B (June 28, 2013)
  • K123998 — QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY (March 8, 2013)
  • K113777 — QUIDEL MOLECULAR INFLUENZA A+B (March 15, 2012)
  • K112172 — QUIDEL MOLECULAR INFLUENZA A + B ASSAY (December 22, 2011)
  • K112490 — QUIDEL MOLECULAR HMPV ASSAY (December 15, 2011)

Other clearances for product code OEM

  • K230349 — Lyra RSV+hMPV Assay (March 10, 2023)
  • K132200 — PRO HMPV+ ASSAY (August 14, 2013)
  • K123838 — PRO HMPV+ ASSAY (January 16, 2013)
  • K112490 — QUIDEL MOLECULAR HMPV ASSAY (December 15, 2011)
  • K082688 — PRO HMPV+ ASSAY (November 7, 2008)