JD Supra

Recent Updates to CLIA Proficiency Testing and Proposed Changes to Fees, Sanctions, and Other Requirements

To maintain the quality of laboratory testing, CLIA requires that laboratories performing moderate or high-complexity testing enroll in an approved proficiency testing program for independent ...
JD Supra

Thinking of Using Serology Testing for COVID-19? Don’t Overlook CLIA Certification Rules

With the spread of COVID-19, healthcare providers—including those that are more easily accessible to patients, like primary care practices and urgent care clinics—are looking for fast and reliable ...
Business Insider

binx health Receives FDA CLIA Waiver for Chlamydia and Gonorrhea Test, Expanding Critical Access to Single-Visit Diagnoses

BOSTON, March 30, 2021 /PRNewswire/ -- binx health, a population health technology company that provides convenient healthcare solutions, announced today that the US Food and Drug Administration (FDA) ...
Nasdaq

QuidelOrtho's (QDEL) Rapid Antigen Test Gets CLIA Waiver

QuidelOrtho Corporation QDEL recently announced that it has been granted a CLIA Waiver by the FDA, which applies to its new Sofia 2 SARS Antigen+ FIA (fluorescent immunoassay). The Sofia 2 SARS ...
FiercePharma

FDA grants CLIA-waived status to CoaguChek XS Plus system for PT/INR testing at the point of care

Exemption of the system from virtually all CLIA rules gives more labs access to connectivity and data management capabilities for monitoring patients on warfarin therapy INDIANAPOLIS, Oct. 1, 2012 ...
Becker's ASC

FDA Approves Five New Tests as Waived Under CLIA

CPT copyright 2010 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. The Food and Drug ...
Medscape

FDA Approves New CLIA-Waived CBC Test for Faster Results

The US Food and Drug Administration (FDA) has cleared a complete blood cell count (CBC) test that can be run in more healthcare settings, including physicians' offices, clinics, or other types of ...
Monthly Prescribing Reference

Rapid Influenza A/B Test Granted CLIA Waiver for Greater Access

The Food and Drug Administration (FDA) has granted the first CLIA waiver for Alere i Influenza A & B test, a nucleic acid-based test, for use in expanded healthcare settings. Prior to this clearance, ...
Nasdaq

Cepheid: FDA 510(k), CLIA Waiver for Point-of-Care Flu Test

Cepheid 's CPHD rapid influenza and RSV assay - the Xpert Flu+RSV Xpress test - recently won the U.S. FDA 510(k) marketing approval and the Clinical Laboratory Improvement Achievements (CLIA) waiver.
Becker's Hospital Review

FDA approves 1st COVID-19 test cleared with CLIA waiver

The FDA cleared for commercial distribution a diagnostic panel that tests for multiple respiratory viral and bacterial infections on Feb. 3. The BioFire Spotfire Respiratory Panel is the first ...

Hickory, NC Urgent Care Adds On-Site CBC Testing to Support Timely Patient Care

HighER Level Urgent Care offers CBC testing enabled by CitoCBC®, a CLIA-waived blood analyzer designed for use in ...
MedCity News

FDA makes it easier for Theranos to conduct testing outside of certified labs

Theranos just received an FDA clearance that’ll allow its newly approved herpes diagnostic to be used outside traditional clinical laboratories. This CLIA Waiver is a sign that the storied ...