CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
January 2024—QuidelOrtho has received FDA 510(k) clearance for its Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of herpes simplex virus types 1 and 2 and varicella zoster virus nucleic acids isolated and purified from swabs obtained from cutaneous or mucocutaneous lesion specimens from symptomatic patients.
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FDA clears QuidelOrtho Savanna platform, HSV 1+2/VZV assay
Dec. 21, 2023—QuidelOrtho has received FDA 510(k) clearance for its Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of herpes simplex virus types 1 and 2 and varicella zoster virus nucleic acids isolated and purified from swabs obtained from cutaneous or mucocutaneous lesion specimens from symptomatic patients.
Read More »QuidelOrtho gets CLIA waiver for Sofia 2 SARS Antigen+ FIA
Sept. 22, 2023—QuidelOrtho has been granted a CLIA waiver from the FDA for its Sofia 2 SARS Antigen+ FIA.
Read More »Newsbytes
September 2023—The musician Frank Zappa said, “One size does not fit all,” a declaration that counters the claims of many clothing manufacturers and holds true for a variety of products, including, one could argue, digital scanners.
Read More »QuidelOrtho gets de novo authorization for Sofia 2 SARS Antigen+ FIA
May 2023—QuidelOrtho Corp. has been granted a de novo request from the FDA for its new Sofia 2 SARS Antigen+ FIA, a lateral flow immunofluorescent assay that is used with the Sofia 2 fluorescent immunoassay analyzer. It is intended for the qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in direct anterior nasal swab specimens from people with signs and symptoms of upper respiratory infection when serial testing is started within six days of symptom onset. The Sofia 2 analyzer provides a result in 10 minutes.
Read More »QuidelOrtho, Runda form joint venture to develop assays
January 2023—QuidelOrtho will form a joint venture between Ortho Clinical Diagnostics Trading, a subsidiary of QuidelOrtho, and Shanghai Medconn Biotechnology, a subsidiary of Shanghai Runda Medical Technology, to develop and manufacture assays in China for QuidelOrtho’s Vitros platform. Following a successful assay pilot program, the companies expect to begin developing a broader set of assays early this year in parallel with building out the joint venture organization in the Shanghai and Beijing areas.
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