Navigation Links
Instrumentation Laboratory Receives FDA Clearance for HemosIL RecombiPlasTin 2G Assay
Date:9/25/2007

- Second Generation Reagent for Blood Coagulation Testing -

LEXINGTON, Mass., Sept. 25 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for HemosIL(R) RecombiPlasTin 2G. This new product is the second generation of HemosIL RecombiPlasTin, one of the most widely used Prothrombin Time (PT) reagents in the world.

HemosIL RecombiPlasTin 2G is performed for pre-surgical screening to evaluate the extrinsic coagulation pathway and to monitor oral anticoagulant therapy. It is based on recombinant tissue factor and a blend of synthetic phospholipids, which allow high sensitivity and lot-to-lot consistency. Additionally, the reagent is insensitive to the new antibiotic Cubicin (daptomycin for injection) and has an ISI value of approximately 1.0 on IL's ACL analyzers, traceable to WHO standards.

"RecombiPlasTin 2G is another example of IL's commitment to continuous product improvement and innovation," said Giovanni Russi, Director of Worldwide Marketing, Hemostasis Reagents at IL. "We are dedicated to delivering the best hemostasis and critical care diagnostics to healthcare providers and ultimately, contributing to the betterment of patient care."

Instrumentation Laboratory (http://www.ilus.com), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories. The company's product lines include critical care systems, hemostasis systems and information management systems. IL's GEM product offerings, part of the critical care line, include the new GEM Premier 4000 analyzer with Intelligent Quality Management (iQM(R)), GEM Premier 3000 analyzer, GEM OPL(TM), a portable whole blood CO-Oximeter and the GEM PCL Plus, a portable Coagulation analyzer. IL's hemostasis por
'/>"/>

SOURCE Instrumentation Laboratory
Copyright©2007 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2

Related medicine technology :

1. New Quality Control Systems for Every Laboratory Application
2. Immunoassay Systems - Your Laboratory Workhorse
3. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
4. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
5. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
6. Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
7. When Volume Matters, Immunoassay Systems Deliver
8. New Assays to Detect Disseminated Fungal Infections
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/17/2013)... 2013 Medical devices are any medical items ... In light of their different mechanisms, actions and regulatory ... complicated than drug trails due to their unique clinical ... of evaluating both safety and efficacy (which is left ... the same as the SFDA) evaluate MDs for both ...
(Date:5/17/2013)... SAN DIEGO and CAMBRIDGE, Mass., May 17, 2013 ... announce that a purchaser of Aveo Pharmaceutical, Inc. (NASDAQGS: ... District Court for the District of Massachusetts ... of its officers violated the Securities Exchange Act of ... May 1, 2013 (the "Class Period"). (Logo: ...
(Date:5/17/2013)... 17, 2013  TechAtlas Group has announced the ... landscape map for the Chronic Kidney Disease (CKD) ... companies with drugs and devices currently on the ... sequelae. (Logo:  http://photos.prnewswire.com/prnh/20130517/NE16011LOGO ... hypertension - renal denervation , diabetic nephropathy ...
Breaking Medicine Technology:Statistical Challenges in Medical Device Trail Evaluation 2Aveo Pharmaceuticals, Inc. Sued by Investor 2Aveo Pharmaceuticals, Inc. Sued by Investor 3TechAtlas Group Releases Innovative Chronic Kidney Disease Landscape Map 2
... TriLink BioTechnologies, Inc. (TriLink), a leader in ... the award of their CleanAmp™ Primer patent by the ... First launched in March of 2008, CleanAmp™ ... next generation Hot Start PCR products. The technology consists ...
... 27, 2011 Genomic Health, Inc. (Nasdaq: GHDX ... present at the following conferences in June: ... the Jefferies 2011 Global Healthcare Conference on Monday, June 6 ... Kim Popovits, Genomic Health,s President and Chief Executive Officer, and ...
Cached Medicine Technology:TriLink BioTechnologies, Inc. Awarded European Patent for CleanAmp™ Primers 2Genomic Health to Present at Two Upcoming Investor Conferences 2Genomic Health to Present at Two Upcoming Investor Conferences 3
(Date:5/18/2013)... Orlando, FL (May 18, 2013) The use ... for a colonoscopy, according to new research presented ... process, which begins days in advance of the ... preparation medication to be taken at strict intervals. ... for doctors to see cancer and precancerous polyps ...
(Date:5/18/2013)... 18, 2013) A ground-breaking advance in colonoscopy ... to research presented today at Digestive Disease Week ... withdrawal time for colonoscopies and exploring safer methods ... doctors use a device called a colonoscope to ... cancer allows a doctor to look for precancerous ...
(Date:5/18/2013)... The “World Healthcare IT Market: Trends & ... market drivers, restraints, and opportunities in North America, Europe, ... 89 market data tables , ... IT Market" , http://www.marketsandmarkets.com/Market-Reports/healthcare-information-technology-market-136.html , ... The global healthcare IT market is expected to grow ...
(Date:5/18/2013)... Wright, KY (PRWEB) May 18, 2013 ... with hearing loss should consider the legal protections they ... claim, when problems arise with their child’s treatment or ... today. , Since 1927, the American Speech-Language-Hearing Association has ... communication disorders and to promote treatment, such as cochlear ...
(Date:5/18/2013)... Florida (PRWEB) May 18, 2013 Adolescents, ... also known as “Spice” or “K2” are landing in ... helping to curb this drug epidemic with a ... synthetic marijuana. , According to research from the National ... second-most popular illegal drug among American teenagers. In 2012, ...
Breaking Medicine News(10 mins):Health News:New smartphone application improves colonoscopy preparation 2Health News:New colonoscope provides ground-breaking view of colon 2Health News:New colonoscope provides ground-breaking view of colon 3Health News:New colonoscope provides ground-breaking view of colon 4Health News:Healthcare IT Market to reach US$ 162.2 Billion by 2015 at a CAGR of 10.2% - New Report by MarketandMarkets 2Health News:Healthcare IT Market to reach US$ 162.2 Billion by 2015 at a CAGR of 10.2% - New Report by MarketandMarkets 3Health News:Schachter, Hendy & Johnson PSC Lawyer Says Cochlear Implant Victims Should Know Their Legal Rights 2Health News:Schachter, Hendy & Johnson PSC Lawyer Says Cochlear Implant Victims Should Know Their Legal Rights 3Health News:Spice Addiction Treatment and Synthetic Marijuana Drug Rehab Announced by Recovery Associates 2
... may take her many steps forward in her career but is ... well known that stress influences eating pattern. A study conducted by ... to adopt certain unhealthy behavior upon working long hours, which can ... or consume too many snacks and may even go overboard on ...
... vocal cord dysfunction (VCD) – an involuntary functional disorder ... in a long-term study published in the current issue ... journal of the American College of Allergy, Asthma and ... and Pulmonary Division at the University of Iowa College ...
... be a wake up call to get the duvets washed and ... their duvets even in six months, and these could// be the ... ,A survey conducted in many households revealed that two ... months. The dust mites and filth are potential health hazards ...
... United Kingdom have lone inhabitants, which means there is a ... surely// an unhealthy trend, say Danish researchers, whose study has ... disease. ,The living alone and ill health ... the 30-69 age bracket. Their lives were studied in detail ...
... Queensland have been reviewed following allegations of inaccuracy by the ... Stephen Robertson there was an unusually low pickup of cancer ... ,9,300 cases were reviewed. Among these 83 women had ... non-malignant cancers. ,Two Gold Coast women are suing ...
... to a large-scale study published in the July issue of ... discontinued the use of Uprima// , a drug known to ... the success rates of this drug. ,And 70 ... an official National Health Service (NHS) drug feedback form felt ...
Cached Medicine News:Health News:Two Distinct Types of Vocal Cord Dysfunction Identified 2Health News:Erection Drug Was Not Useful to Two-Thirds of Its Users 2Health News:Erection Drug Was Not Useful to Two-Thirds of Its Users 3
... Bird and Cronin, ... manufacturer of Patient Footwear, ... Patient Care Products. Our ... highest quality and available ...
AchilloTrain is a comfortable knitted support with a silicone insert alongside the Achilles tendon and under the heel. An additional heel cushion is provided for the unaffected foot. It is worn to tr...
DarcoGel™ Upper chamber is foam filled, conforms to calf; gel-filled lower chamber molds to the malleoli for a custom fit. Freeze the removable liner for cold therapy. One size. Fits left or ri...
... maintaining the ankle in functional alignment. Entire ... cushioning AliPlast™ foam liner. The cushioning air ... heel in a protective hammock, reducing ulceration ... bed from side-lying to supine. Only the ...
Medicine Products: