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510(k) K123998

QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY by Quidel Corp. — Product Code OZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2013
Date Received
December 26, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C. Difficile Toxin Gene Amplification Assay
Device Class
Class II
Regulation Number
866.3130
Review Panel
MI
Submission Type

Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.

Other clearances by Quidel Corp.

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  • 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)
  • K122189 — QUIDEL MOLECULAR RSV + HMPV 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)

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  • K210385 — cobas Cdiff nucleic acid test for use on the cobas Liat System (September 9, 2021)
  • K172569 — GenePOC CDiff (November 22, 2017)
  • K171770 — cobas Cdiff Nucleic acid test for use on the cobas Liat System (September 12, 2017)
  • K171441 — ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Ki (July 21, 2017)
  • K170491 — Solana C. difficile Assay (May 11, 2017)
  • K163085 — Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack (February 14, 2017)
  • K142422 — cobas Cdiff Test (May 20, 2015)