Navigation Links
BD Supports the FDA's Proposal to Reclassify Rapid Influenza Tests
Date:8/26/2013

FRANKLIN LAKES, N.J., Aug. 26, 2013 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, supports the U.S. Food and Drug Administration's (FDA's) proposed reclassification of rapid influenza detection tests.  A hearing, held on June 13th by FDA's CDRH Microbiology Devices Advisory Committee Meeting, examined the FDA's proposal to reclassify rapid influenza detection tests (RIDTs) currently regulated as Class I devices, into Class II devices.

The recent 2009 flu pandemic has emphasized the poor performance of point-of-care flu tests available at the time. The new performance standards will provide healthcare providers with criteria for evaluating the tests that they use. The proposal would increase performance requirements for RIDTs to attain at least a sensitivity of 90 percent for influenza A and 80 percent for influenza B versus viral culture and/or 80 percent versus polymerase chain reaction (PCR) methods. If these minimum clinical performance criteria are not met, marketed devices will need to be withdrawn from the market one year after the rule is finalized. This proposal culminates years of publications showing that many of the visual read RIDTs had poor sensitivity when compared to viral culture and to reverse transcription PCR methods.

"This proposal is a step in the right direction as physicians and hospitals routinely rely on rapid diagnostic influenza tests to help manage patients that are suspected of having influenza," said Tom Polen, President, BD Diagnostics – Diagnostic Systems. "Raising the standards of rapid influenza tests will provide healthcare providers the right information to guide patient diagnosis and treatment without requiring repeat testing."

BD pioneered the development of a higher performing test
'/>"/>

SOURCE BD-Becton Dickinson
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Pharmaceutics International, Inc. (Pii) Supports University Pharmaceutical Technology Education and Research
2. Data Presented at the American Psychiatric Association Annual Meeting Supports Gender-Specific Dosing of Intermezzo® (zolpidem tartrate) Sublingual Tablets CIV
3. U.S. Government Supports Phase 3 Study of Bavarian Nordics Smallpox Vaccine
4. Frost & Sullivan: Expanding Sample Prep Market Supports Growth Trends in Molecular Diagnostics Markets
5. New Legislation To Make USPSTF More Transparent: Prostate Cancer Roundtable Supports Reform
6. Ventana Supports World Patient Safety Day, July 25
7. eCardio Supports the Carolinas HealthCare Foundation Through Grant for Heart Of A Champion Day
8. Verify Brand Supports the Proposed FDA Unique Device Identification (UDI) System for Medical Devices
9. Lilly Supports Research to Determine What a Dogs Nose Knows About People with Diabetes and Severe Hypoglycemia
10. Henry Schein Cares Supports Alliance for Oral Health Across Borders Leadership Event
11. Cardinal Health Supports Future Pharmacists With Nearly $1 Million In Scholarships
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/2/2015)... , June 2, 2015  Endo International plc (NASDAQ: ... announced today that it has commenced an underwritten public ... All ordinary shares in the offering are to be ... also grant to the underwriters of the Offering an ... the date of the final prospectus supplement, to purchase ...
(Date:6/2/2015)...  MGC Diagnostics Corporation (NASDAQ: MGCD ), ... results for the second quarter ended April 30, ... equipment, supplies and accessories revenues, compared to the ... During the quarter, competitive account conversions totaled 12 ... accounts, or $850,000 in revenue for the same ...
(Date:6/2/2015)... 2, 2015   PDI , a leader ... a series of corporate commitments designed to educate ... the threat of antimicrobial-resistant microorganisms as part of ... Disease Control and Prevention (CDC) and in support ... Antibiotic-Resistant Bacteria. Along with other key ...
Breaking Medicine Technology:Endo International plc Announces Proposed Public Offering of $1.75 Billion of Ordinary Shares 2Endo International plc Announces Proposed Public Offering of $1.75 Billion of Ordinary Shares 3Endo International plc Announces Proposed Public Offering of $1.75 Billion of Ordinary Shares 4MGC Diagnostics Corporation Reports Fiscal 2015 Second Quarter Results 2MGC Diagnostics Corporation Reports Fiscal 2015 Second Quarter Results 3MGC Diagnostics Corporation Reports Fiscal 2015 Second Quarter Results 4MGC Diagnostics Corporation Reports Fiscal 2015 Second Quarter Results 5MGC Diagnostics Corporation Reports Fiscal 2015 Second Quarter Results 6MGC Diagnostics Corporation Reports Fiscal 2015 Second Quarter Results 7MGC Diagnostics Corporation Reports Fiscal 2015 Second Quarter Results 8MGC Diagnostics Corporation Reports Fiscal 2015 Second Quarter Results 9MGC Diagnostics Corporation Reports Fiscal 2015 Second Quarter Results 10MGC Diagnostics Corporation Reports Fiscal 2015 Second Quarter Results 11MGC Diagnostics Corporation Reports Fiscal 2015 Second Quarter Results 12MGC Diagnostics Corporation Reports Fiscal 2015 Second Quarter Results 13MGC Diagnostics Corporation Reports Fiscal 2015 Second Quarter Results 14PDI Partners with White House and Centers for Disease Control and Prevention (CDC) to Combat Antimicrobial Resistance 2
... TORONTO, Nov. 8, 2010 Millennium Research Group ... intelligence, has released its latest surgical navigation systems ... geographies. These two reports cover the breakdown of ... used in neurosurgery, spine, ENT, orthopedic, and soft ...
... SALT LAKE CITY, Nov. 8, 2010 TechniScan, Inc. ... device company engaged in the development and commercialization of an ... its convertible debt. TechniScan entered into amendments with ... extend the maturity date of its entire portfolio of secured ...
Cached Medicine Technology:Medtronic, Stryker, and BrainLAB Covered in New Surgical Navigation Market Research Reports Released by Millennium Research Group 2TechniScan, Inc. Announces Restructuring of Convertible Debt 2
(Date:6/3/2015)... evigilo, a world leader in delivering ... new branding by launching a new and enhanced content-centric ... identity: the logo depicting a sun-like image with a ... – To Know. To Act. In time. The color ... A global, borderless approach to alerting and delivering safety ...
(Date:6/2/2015)... Prairie, WI (PRWEB) June 03, 2015 ... for regulated industries such as government, finance and healthcare. ... organization that wants reliable access control to enhance the ... card keyboard requires the secondary authentication of a Smart ... In addition to the smart-chipset card reader, the keyboard ...
(Date:6/2/2015)... MEDIA ADVISORY, June 2, 2015 ... Email: ewallace(at)mentalhealthamerica(dot)net , Breaking News: Congressman Tim Murphy ... at MHA Annual Conference Thursday , Who: Congressman ... address the Mental Health America Annual Conference attendees ... of the Helping Families in Mental Health Crisis ...
(Date:6/2/2015)... Los Angeles, CA (PRWEB) June 02, 2015 ... clinic have unveiled a plan to drive prolific change in ... progress, the TDC Team Dental Clinic offers a ... and an expert management structure for dental tourism. , Partnered ... dental care team is committed to advancing dentistry and has ...
(Date:6/2/2015)... UCLA Health and Exer have completed negotiations and ... urgent care services in Los Angeles County. The ... California Board of Regents and the Exer Board of ... purchase a minority share of four existing Exer urgent ... Northridge and creates opportunity to grow and develop new, ...
Breaking Medicine News(10 mins):Health News:Keep calm! evigilos' "sun" will come out tomorrow – to know, to act, in time. 2Health News:Introducing the New CHERRY JK-A0100EU Keyboard with Integrated Smart Card Reader for Access Control Security 2Health News:Congressman Tim Murphy to Unveil Details of New Mental Health Legislation at MHA Annual Conference Thursday 2Health News:Team Dental Clinic Unveils Plan to Drive Change in the Dental Tourism Industry 2Health News:Team Dental Clinic Unveils Plan to Drive Change in the Dental Tourism Industry 3Health News:UCLA Health Partners With Exer - More Than Urgent Care 2
... to earn the dubious distinction of becoming a country with ... better emergency facilities for heart patients could save lives, feel ... reports, India is likely to become the heart attack capital ... been spreading like an epidemic and have been affecting the ...
... Onyx Pharmaceuticals, Inc. today announced that Nexavar(R) (sorafenib) ... with hepatocellular carcinoma (HCC), or primary liver cancer ... presented at the 43rd annual meeting of the ... ,The international, Phase 3, placebo-controlled Sorafenib HCC Assessment ...
... two new investigational cancer therapies at the American Society ... a small molecule inhibitor of Poly-ADP Ribose Polymerase (PARP). ... Excision Repair which is a key pathway in the ... mechanism, in tandem with a defective DNA repair gene ...
... 4, 2007 An international team led by MUHC has ... is a common congenital blindness in infants and small children. ... Nature Genetics and is partly funded by the Foundation Fighting ... potential to fast-track a cure for this disease, says lead ...
... The winds of change and a yearning for variety are ... vodka and gin even as the old generation still ... ,As part of the global trend, the consumption of ... up in the subcontinent, thanks to the changing profile of ...
... to a University of Pittsburgh Medical Center (UPMC) study ... of Clinical Oncology (ASCO) in Chicago and published as ... for follicular lymphoma, a slow-growing type of non-Hodgkins lymphoma, ... ,Over 90 percent of study patients responded completely to ...
Cached Medicine News:Health News:Nexavar Significantly Extends Survival of Liver Cancer Patients 2Health News:Astrazeneca's Investigational Cancer Therapies Revealed at ASCO 2Health News:Astrazeneca's Investigational Cancer Therapies Revealed at ASCO 3Health News:Gene Responsible for Blindness in Infants and Children Identified 2Health News:Young Indians Say Cheers to White Spirits 2Health News:Young Indians Say Cheers to White Spirits 3Health News:Lymphoma Patients Maybe Helped by Adding Radioimmunotherapy to Chemo 2
QIAvac 6S provides all manifold components for processing QIAGEN 8-well strips....
Holder for QIAGEN 96-well plates, for use with QIAvac 96;...
For processing mini spin columns on QIAvac 24;...
DNA/RNA preparation in 384-well format...
Medicine Products: