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Tag Archives: Quidel—

Solana Bordetella assay cleared

September 2018—Quidel received 510(k) clearance from the FDA to market its Solana Bordetella Complete Assay, a molecular diagnostic assay for use with the Solana instrument for the qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids isolated from nasopharyngeal swab specimens.

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Fingerstick Sofia 2 Lyme FIA gets FDA clearance, CLIA waiver

Sept. 6, 2018—Quidel has received 510(k) clearance and Clinical Laboratory Improvement Amendments waiver from the FDA to market its Sofia 2 Lyme FIA to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from fingerstick whole blood specimens from patients suspected of B. burgdorferi infection. The test is ...

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FDA clears POC Sofia Lyme FIA for Sofia 2

March 15, 2018—Quidel received 510(k) clearance from the FDA to market its Sofia Lyme FIA to be used with the Sofia 2 fluorescent immunoassay analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection, which causes Lyme disease. “The Sofia Lyme Assay’s 510(k) ...

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FDA-cleared respiratory infection assay, 3/18

March 2018—Quidel has received clearance from the FDA to market its Solana respiratory syncytial virus plus human metapneumovirus assay for the detection of nucleic acids isolated from nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection to aid in the diagnosis of RSV and/or hMPV infections.

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FDA clears QuickVue Influenza A+B test

Feb. 27, 2018—Quidel announced it has received FDA 510(k) clearance for its CLIA-waived QuickVue Influenza A+B assay. The assay allows for the rapid, qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients in approximately 10 minutes. In a clinical study, the QuickVue Influenza A+B test was shown to ...

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Sofia Strep A+ Assay lands FDA 510(k) clearance

Jan. 5, 2018—Quidel received 510(k) clearance and CLIA waiver from the FDA for its Sofia Strep A+ Fluorescent Immunoassay (FIA) for use with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of infections by group A streptococcus bacteria. Sofia Strep A+ is the third CLIA-waived assay available on the Sofia 2 system, following the Sofia Influenza A+B and ...

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FDA approves Sofia Lyme FIA, 12/17

December 2017—Quidel received 510(k) clearance from the FDA to market its Sofia Lyme FIA for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection. The test is intended for use with the Sofia analyzer to aid in the diagnosis of Lyme disease.

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Quidel’s Sofia Lyme FIA gets FDA approval

Nov. 27, 2017—Quidel received 510(k) clearance from the United States Food and Drug Administration to market its Sofia Lyme FIA for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection. The test is intended for use with the Sofia analyzer to aid in the ...

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