Alere Receives FDA Clearance for Modified Influenza A & B Test

Jan 16, 2017

|

NEW YORK (360Dx) – The US Food and Drug Administration has issued 510(k) clearance for the Alere i Influenza A & B panel, Alere i Influenza A & B control swab kit, and the Alere i instrument.

The agency late last month issued the clearance, which allows Alere to market the device in the US.

To read the full story....

...and receive Daily News bulletins.

Already have a 360Dx or GenomeWeb account?
Login Now.

Don't have a 360Dx or GenomeWeb account?
Register for Free.

Featured White Papers

For In Vitro Diagnostic Materials: Efficacy vs. Thimerosal and Sodium Azide

Development of a Quantitative Lateral Flow Test Using Estapor Europium Microspheres

Performance of Estapor Microspheres and Hi-Flow Plus Membranes in a Lateral Flow Assay for Human Chorionic Gonadotropin (hCG)

ProClin 300 Preservative: An In-Depth Technical Analysis

Apr

13

Featured Webinar

An Opportunity Arises from the Pandemic: The Promise of Targeted NGS for SARS-CoV-2 Detection

Mitigation of the SARS-CoV-2 pandemic will continue to require innovative solutions. This webinar will outline how Fry Laboratories rapidly redeployed a next-generation sequencing (NGS) pipeline originally created for the detection and identification of bacterial, eukaryotic, and fungal infections in response to SARS-CoV-2.

Apr

16

Featured Webinar

The Post-Vaccine COVID Testing Landscape: A Virtual Roundtable Discussion

With COVID-19 vaccines rolling out, clinical labs and test developers are preparing for changes in both demand for testing and types of testing for SARS-CoV-2.

Apr

29

Featured Webinar

A New Generation of PCR: At-home Testing and Preparing for Emerging Strains of COVID-19

Join Dr. Heather Fehling, Chief Scientific Officer at Clinical Reference Labs (CRL), as she provides some insights regarding the future applications of PCR testing.

May

13

Featured Webinar

Limits of Detection Matter: New Challenges for SARS-CoV-2 Diagnostics and COVID-19 Patient Management

As we pass the one-year anniversary of both the COVID-19 pandemic and the first Emergency Use Authorized SARS-CoV-2 PCR detection assays, there remains significant opportunity for clinical laboratories to advance testing and support improved patient management.

Menu

Alere Receives FDA Clearance for Modified Influenza A & B Test

To read the full story....

Breaking News

Novacyt in Dispute with UK Department of Health and Social Care Over Coronavirus Test Contract

In Brief This Week: Bio-Techne, Mologic, Caris Life Sciences, And More

BioMérieux Gets CE Mark for Three Dengue Immunoassays

Hologic to Acquire Finnish MDx Firm Mobidiag for Approximately $795M

LumiraDx to Go Public on Nasdaq Through SPAC

Roche Elecsys Anti-p53 Test for Cancer Diagnosis Earns CE Mark

Featured White Papers

An Opportunity Arises from the Pandemic: The Promise of Targeted NGS for SARS-CoV-2 Detection

The Post-Vaccine COVID Testing Landscape: A Virtual Roundtable Discussion

A New Generation of PCR: At-home Testing and Preparing for Emerging Strains of COVID-19

Limits of Detection Matter: New Challenges for SARS-CoV-2 Diagnostics and COVID-19 Patient Management

What's Popular?

CLIA Waiver in Hand, Binx Health Targeting Retailers, Urgent Care Centers With STI Tests

Hologic to Acquire Finnish MDx Firm Mobidiag for Approximately $795M

Novacyt in Dispute with UK Department of Health and Social Care Over Coronavirus Test Contract

Armed With $55M in New Funding, Nucleix to Further Invest in Early-Stage Lung Cancer Dx

LumiraDx to Go Public on Nasdaq Through SPAC

Sponsorships