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ADEXUSDx® hCG Test
FDA 510k Cleared & CE Marked
The ADEXUSDx® hCG Test is an immunoassay used for the qualitative detection of human chorionic gonadotropin in human whole blood, plasma, or serum.
ADEXUSDx® H-FABP Test
CE Marked. Not available in the U.S.
The ADEXUSDx® H-FABP Test is an immunoassay used for the qualitative detection of human Heart Fatty Acid Binding Protein in human whole blood, plasma, or serum samples.
ADEXUSDx® Acetaminophen Test
CE Marked. Not available in the U.S.
The ADEXUSDx® Acetaminophen Test is an enzymatic assay used for the qualitative detection of elevated acetaminophen levels in human whole blood, plasma, or serum.
ADEXUSDx® Troponin I Test
CE Marked. Not available in the U.S.
The ADEXUSDx® Troponin I Test is an immunochromatographic assay used for the qualitative detection of human cardiac Troponin I above an established cut-off in human whole blood, plasma, or serum.
ADEXUSDx® Salicylate Test
CE Marked. Not available in the U.S.
The ADEXUSDx® Salicylate Test is an enzymatic assay used for the qualitative detection of salicylate above an established cut-off in human whole blood, plasma, or serum.
ADEXUSDx® Methanol Dip Test
CE Marked. Not available in the U.S.
The ADEXUSDx® Methanol Dip Test is an enzymatic assay used for the qualitative detection of methanol above an established cut-off in human whole blood, plasma, or serum.
ADEXUSDx® Troponin I/Myoglobin (TnI/Myo) Test
CE Marked. Not available in the U.S.
The ADEXUSDx® Troponin I/Myoglobin (TnI/Myo) Test is an immunochromatographic assay used for the qualitative detection of human cardiac Troponin I and Myoglobin in human whole blood, plasma, or serum.
NOW BY THE NUMBERS
8
WHO patents and applications
36
Tests in the pipeline
7
Tests for sale in Europe
10
Minutes average result time
IN THEIR WORDS
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Bloomberg Business
Bloomberg Business“NOWDiagnostics Inc. Receives FDA Clearance for ADEXUSDx hCG Test”
August 19, 2015
NOWDiagnostics’ ADEXUSDx hCG point-of-care test, which uses only a single drop of capillary or whole blood to quickly and accurately diagnose pregnancy earlier than urine-based tests, has now been CLIA registered and classified by the U.S. Food and Drug Administration.
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BioSpace
BioSpace“NOWDiagnostics Wins FDA Approval for ADEXUSDx hCG Test”
August 13, 2015
NOWDiagnostics’ ADEXUSDx hCG point-of-care test, which uses only a single drop of capillary or whole blood to quickly and accurately diagnose pregnancy earlier than urine-based tests, has now been CLIA registered and classified by the U.S. Food and Drug Administration.
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FDA News
FDA News“NOWDiagnostics Gets 510(k) Approval for Blood Pregnancy Test”
August 14, 2015
NOWDiagnostics has received 510(k) clearance from the FDA for its ADEXUSDx blood test, which accurately diagnoses pregnancies two to eight days earlier than urine-based tests.
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Fierce Medical Devices
Fierce Medical Devices“NOWDiagnostics gets FDA blessing for one-step pregnancy test”
August 14, 2015 | By Emily Wasserman
NOWDiagnostics nabbed an FDA OK for its one-step pregnancy blood test, a win for the company as it builds out its offerings and vies for a share of a rapidly expanding pregnancy testing market.
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Smart Brief
Smart Brief“FDA clears blood pregnancy test from NOWDiagnostics”
August 14, 2015
The ADEXUSDx, a blood test designed by NOWDiagnostics to detect pregnancies in 10 minutes, has received 510(k) clearance from the FDA. The Springdale, Ark., firm said the product delivers faster results than urine-based tests.
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Medical Devices Business Review
Medical Devices Business Review“NOWDiagnostics acquires Canada’s ZBx”
September 2, 2015
NOWDiagnostics recently completed its acquisition of ZBx Corporation of Canada, a move that brings the company closer to its vision of a world where people have greater access to information concerning their health.
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Small Business Trends
Small Business Trends“NOWDiagnostics Inc. Acquisition Benefits Small Health Practitioners”
September 7, 2015 | By JoAnn McFarland
Small healthcare businesses that constantly outsource their patient lab work may benefit from a recent deal. NOWDiagnostics Inc., based in Springdale, Arkansas, has acquired ZBx Corporation of North York, Ontario, Canada.
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LabMedica
LabMedica“Diagnostic Company Acquisition to Ease Market Entry and Shorten Development Time for New Tests”
September 15, 2015
Two North American manufacturers of rapid diagnostic tests are combining in order to pool their products for rapid entry into the diagnostic product market and to boost development of new tests.
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Med City News
Med City News“NOWDiagnostics is using quick fingertip-prick blood testing to identify disease, and it’s fully approved… (A step above Theranos?)”
January 4, 2016 | By Nicole Oran
A focus on relatively painless, quick diagnostic testing didn’t just bring Theranos to the forefront (despite its recent hurdles). Companies like NOWDiagnostics, established in the beginning of 2014, have had a similar focus and have found success in taking a drop of blood from the fingertip and allowing for solid results in just minutes.