Medical Device Manufacturer · US , Washington , DC

Quidel Corp.

93 submissions · 93 cleared · Since 1983
93
Total
93
Cleared
0
Denied

Quidel Corp. has 93 FDA 510(k) cleared medical devices. Based in Washington, US.

Historical record: 93 cleared submissions from 1983 to 2013. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Quidel Corp. Filter by specialty or product code using the sidebar.

93 devices
1–12 of 93
QUIDEL MOLECULAR RSV + HMPV ASSAY
K131813 · OCC Respiratory Virus Panel Nucleic Acid Assay System · Microbiology
Sep 2013 78d
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K131728 · OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay · Microbiology
Aug 2013 78d
SOFIA(R) RSV FIA
K130398 · GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · Microbiology
Aug 2013 175d
SOFIA(R) HCG FIA
K131166 · JHI Visual, Pregnancy Hcg, Prescription Use · Chemistry
Aug 2013 100d
SOFIA INFLUENZA A+B FIA
K131606 · GNX Antigens, Cf (including Cf Control), Influenza Virus A, B, C · Microbiology
Jul 2013 32d
QUICKVUE INFLUENZA A+B
K131619 · GNX Antigens, Cf (including Cf Control), Influenza Virus A, B, C · Microbiology
Jun 2013 25d
QUIDEL MOLECULAR RSV + HMPV ASSAY
K122189 · OEM Human Metapneumovirus (hmpv) Rna Assay System · Microbiology
Mar 2013 227d
QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
K123998 · OZN C. Difficile Toxin Gene Amplification Assay · Microbiology
Mar 2013 72d
QUIDEL MOLECULAR INFLUENZA A+B
K113777 · OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay · Microbiology
Mar 2012 85d
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K112172 · OCC Respiratory Virus Panel Nucleic Acid Assay System · Microbiology
Dec 2011 147d
QUIDEL MOLECULAR HMPV ASSAY
K112490 · OEM Human Metapneumovirus (hmpv) Rna Assay System · Microbiology
Dec 2011 108d
SOFIA ANALYZER AND INFLUENZA A+B FIA
K112177 · PSZ Devices Detecting Influenza A, B, And C Virus Antigens · Microbiology
Oct 2011 88d

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All93 Chemistry 39 Microbiology 36 Immunology 18