Binaxnow malaria test device alere
WebDevice Classification Name: devices detecting influenza a, b, and c virus antigens: 510(k) Number ... K162642: Device Name: Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit: Applicant: ALERE SCARBOROUGH, INC. 10 SOUTHGATE ROAD: SCARBOROUGH, ME 04074 … WebBinaxNOW™ Malaria Reagent A Safety Data Sheet This document has been prepared in accordance with the SDS requirements of the OSHA Hazard Communication Standard 29 CFR 1910.1200 2024 06 07 EN (English US) 2/7 Full text of hazard classes and H-statements : see section 16 SECTION 4: First-aid measures 4.1. Description of first aid …
Binaxnow malaria test device alere
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WebDEVICE: BinaxNOW® Malaria (10811877010361) Download ... Company Name: Alere Scarborough, Inc. Primary DI Number: 10811877010361 Issuing Agency: GS1 Commercial Distribution End Date: ... laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point …
WebMalaria Diagnostic Tests Microscopy Rapid Diagnostic Test Serology Malaria Diagnosis (U.S.) - Microscopy Microscopic examination remains the “gold standard” for laboratory confirmation of malaria. These tests … WebDevice Name: The BinaxNOW® Malaria Positive Control.. Company Name: Alere Scarborough, Inc.. Brand Name: BinaxNOW® Malaria Positive Control Kit. Global Unique Device ID: 10811877010712. Version (Model) Number: 665-010. Device Name: The BinaxNOW® Malaria Positive Control.. ... 00811877011712 — BinaxNOW COVID-19 …
WebApr 24, 2006 · BinaxNOW®Influenza A&B Test Kit Cat. #416-000, 416-110, 416-022, 41603J, 416-110J Nasopharyngeal Swab Specimen Accessory Pack Cat. #400-065 Control Swab Accessory Pack Cat. #416-080 THE FOLLOWING INFORMATION PROVIDED IS BELIEVED TO BE CORRECT AND ACCURATE. WebDescription. A rapid and simple diagnostic test that can accurately differentiate a deadly P. falciparum infection from a pan-malarial infection caused by P. vivax, P. ovale, or P. malariae. For differential diagnosis of …
WebThe BinaxNOW® Malaria test is an in vitro immunochromatographic assay for the qualitative detection of Plasmodium antigens circulating in human venous and capillary EDTA whole blood of individuals with signs and symptoms of malarial infection. The test targets the histidine-rich protein II (HRPII) antigen...
WebTrade/Device Name: Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit Regulation Number: 21 CFR 866.3328 Regulation Name: Influenza virus antigen detection test systems Regulatory Class: Class II Product Code: PSZ Dated: November 10, 2024 Received: November 13, 2024 Dear … rays logisticsWebThe Alere BinaxNOW® Malaria Positive Control is intended for use as an assayed positive external quality control with the qualitative Alere BinaxNOW® Malaria Test. It is designed for routine use to aid in verifying proper performance of the procedure and the antigen detection reagents of the Alere simply elegant party \u0026 event rentalsWebDiagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses (issued on: July 15, 2011). L. Test Principle: The test is based on the antigen-antibody binding properties characteristic of immunoassays. The Alere BinaxNOW ® Influenza A & B Card 2 uses highly sensitive recombinant ray slush from san antonio texasWebThe BinaxNOW® Malaria Positive Control. BinaxNOW® Malaria Positive Control Kit - 665-010. Device Description. A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from multiple species of Plasmodium, the malaria parasites (e.g., P. falciparum, P. vivax, P. ovale, P. … raysloffWebTest Kits Rapid Test Kit #721094 Abbott Rapid Dx North America LLC #665025 Rapid Test Kit BinaxNOW® Infectious Disease Immunoassay Malaria Whole Blood Sample 25 Tests TEST KIT, BINAX NOW MALARIA (25/KT) WAMPL Compare Log in for pricing and availability Log In to Order or View Alternatives Product Specifications Professionals Also … rays luplowThe BinaxNOW™ Malaria test is an in vitro immunochromatographic assay for the qualitative detection of Plasmodium antigens circulating in human venous and capillary EDTA whole blood of individuals with signs and symptoms of malarial infection. The test targets the histidine-rich protein II (HRPII) … See more raysl soccerWebDescription. Immunochromatographic assay for the qualitative detection of RSV fusion protein antigen in neonatal and pediatric patients under the age of five. Time for test results: 15 minutes. Sample type: Nasal wash and nasopharyngeal (NP) swabs. Nasal Wash: Sensitivity 89%, Specificity 100%. rays logo black and white