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510(k) K131606

SOFIA INFLUENZA A+B FIA by Quidel Corp. — Product Code GNX

K131606 is an FDA 510(k) premarket notification submitted by Quidel Corp. for the device "SOFIA INFLUENZA A+B FIA". The FDA issued a decision of Substantially Equivalent on July 5, 2013. The device falls under product code GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. Quidel Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2013
Date Received
June 3, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Device Class
Class I
Regulation Number
866.3330
Review Panel
MI
Submission Type

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)
  • K131619 — QUICKVUE INFLUENZA A+B (June 28, 2013)
  • K122189 — QUIDEL MOLECULAR RSV + HMPV ASSAY (March 8, 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 GNX

  • K133411 — ALERE BINAXNOW INFLUENZA A & B CARD (December 5, 2013)
  • K132352 — SAS FLUALERT A & B, SAS INFLUENZA A TEST (August 22, 2013)
  • K131804 — REMEL XPECT FLU A&B (July 12, 2013)
  • K131599 — QUICK VUE INFLUENZA (July 5, 2013)
  • K131619 — QUICKVUE INFLUENZA A+B (June 28, 2013)
  • K123182 — OSOM INFLUENZA A&B TEST MODEL 190 (November 5, 2012)
  • K971494 — VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES (September 10, 1997)
  • K924006 — BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY (December 29, 1992)
  • K901493 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (June 27, 1990)
  • K893579 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (January 16, 1990)

FDA data resources