BD Launches Combo Test for SARS-CoV-2, Influenza & Respiratory Syncytial Virus
The BD MAX Respiratory Viral Panel is a diagnostic combination test for SARS-CoV-2, Influenza A + B and Respiratory Syncytial Virus (RSV).
Category: Immunoassay Reagents & test Kits
Immunoassay Reagents & test Kits
Latest
Immunoassay Reagents & test Kits
Latest
FDA Grants Quanterix Breakthrough Device Designation for Multiple Sclerosis NfL Test
The NfL plasma test has been granted Breakthrough Device designation as a prognostic aid for patients diagnosed with relapsing-remitting MS.
Immunoassay Reagents & test Kits
Latest
Helix COVID Test with ‘Locker’ System Gets Emergency Use Authorization
Helix received FDA Emergency Use Authorization for its SARS-CoV-2 Test and Helix COVID-19 Self-Collection Kit.
FDA Authorizes On/Go One Compact, Rapid Antigen COVID Test
The new antigen test delivers results with 98.2% accuracy in 15 minutes and detects all major known variants, including Omicron, via an easy-to-use test.
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New COVID-19 Testing Location Opens in Nebraska as Omicron Spreads
GS Labs offers rapid antigen tests, PCR tests, rapid PCR, and LAMP tests, and a combination rapid antigen COVID and flu test.
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FDA Expands ChromaCode’s HDPCR SARS-CoV-2 Assay Emergency Use Authorization
The FDA has expanded the EUA of ChromaCode’s HDPCR SARS-CoV-2 Assay to include several new qPCR instruments and use of 384-well plates.
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Cardinal Health to Distribute Cue Health COVID-19 Tests
Cue Health and Cardinal Health are partnering for the distribution of Cue’s professional use and over-the-counter COVID-19 tests.
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FDA Recalls E25Bio’s COVID Rapid Antigen Test
E25Bio is recalling its COVID-19 Direct Antigen Response Tests after it was discovered they were distributed to U.S. customers without FDA approval.
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Magellan Diagnostics Resumes Distribution of LeadCare II Test Kits
Magellan Diagnostics has resumed manufacturing the kits—a test for childhood lead exposure—which was originally suspected of having a defect.
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COVID Testing Efforts Expand for Retailers
eTrueNorth and the United States Department of Health and Human Services collaborated on a COVID testing model that expands testing at retailers.
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Labcorp Launches New Digital Health Platform
The new platform includes a suite of the company’s most popular tests, including its wellness, allergy, COVID-19, women’s health, and fertility tests.
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Avellino’s New Combination Test Detects Four Viral Infections in One Sample
Avellino Lab USA launched a multi-panel RT-PCR-based virus assay that can detect COVID-19, respiratory syncytial virus (RSV), influenza A, and influenza B.
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New England Biolabs Launches its First Lyophilized Product
New England Biolabs released its first lyophilized product manufactured by Fluorogenics: the LyoPrime Luna Probe One-Step RT-qPCR Mix with UDG.
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Scientists Develop Smartphone-Based COVID Test
The detection system can be readily adapted for other pathogens with pandemic potential, including deadly variants of COVID and flu.
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Millions of Siemens Healthineers’ New Rapid COVID Antigen Self-Test Available in the U.S.
Earlier this year, Siemens Healthineers committed to making tens of millions of tests available for the federal government.
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InteliSwab COVID Rapid Tests are FDA Authorized for Pediatric Use
OraSure conducted studies to evaluate the performance of the test in a pediatric population, and evaluated usability and tolerability by children.
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How Consumers Interpret COVID-19 At-Home Test Results
Researchers also found that CDC information for consumers was hard to follow, distributed across multiple webpages, poorly summarized, and not consistent.
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FDA: Class 1 Recall of Empowered Diagnostics COVID Tests
The FDA issued a Class I recall, the most serious type of recall, for two Empowered Diagnostics COVID-19 Tests.
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