Inverness Medical Binax Now Malaria

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BinaxNOW Malaria | Abbott Point of Care

https://www.globalpointofcare.abbott/en/product-details/binaxnow-malaria.html

The BinaxNOW™ Malaria test is an in vitro immunochromatographic assay for the qualitative detection of Plasmodium antigens circulating in human venous and …

CDC - DPDx - Diagnostic Procedures

https://www.cdc.gov/dpdx/diagnosticprocedures/blood/antigendetection.html

May 3, 2016

Notice to Readers: Malaria Rapid Diagnostic Test - Centers for …

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5627a4.htm

On June 13, 2007, the Food and Drug Administration approved BinaxNOW ® Malaria (Inverness Medical Professional Diagnostics, Scarborough, Maine), the first malaria …

Abbott™ BinaxNOW™ Malaria Tests

https://www.fishersci.com/shop/products/alere-binaxnow-malaria-tests-3/p-3987135

Abbott™ BinaxNOW™ Malaria Tests Rapid malaria test cleared by the FDA Specifications View More Specs Products 3 Description Specifications Description A rapid …

BinaxNOW Malaria FDA cleared | SelectScience

https://www.selectscience.net/product-news/binaxnow-malaria-fda-cleared/?artID=13563

Inverness Medical offers BinaxNOW Malaria for the rapid diagnosis of malaria infection - the only rapid test for malaria cleared by the FDA. BinaxNOW …

Notice to Readers: Malaria Rapid Diagnostic Test - JAMA

https://jamanetwork.com/journals/jama/fullarticle/208984

MMWR. 2007;56:686. On June 13, 2007, the Food and Drug Administration approved BinaxNOW® Malaria (Inverness Medical Professional Diagnostics, …

Performance of BinaxNOW for diagnosis of malaria in a U.S.

https://pubmed.ncbi.nlm.nih.gov/22718936/

Overall, BinaxNOW was 84.2% sensitive and 99.8% specific. Excluding patients on antimalarial therapy, the sensitivity was 92.9%. Importantly, BinaxNOW initially …

HUMAN - accessdata.fda.gov

https://www.accessdata.fda.gov/cdrh_docs//pdf6/k061542.pdf

Binax NOW® Malaria Test as a prescription device under 21 CFR Part 801.109 that is . intended for the qualitative detection of. Plasmodium . antigens circulating in human …

Inverness Medical announces FDA clearance of the BinaxNOW …

https://www.reuters.com/article/idUSIN20070628074530IMA20070628

The BinaxNOW test is the first and only rapid malaria test available in the US. Co announces that it received 510(k) clearance from the FDA to market the …

Device Classification Under Section 513(f)(2)(De Novo) - Food …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN070006

510 (K) Number. K061542. Device Name. BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX. Requester. INVERNESS MEDICAL PROFESSIONAL …

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