FDA Clearance of Lactate Test
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FDA Clearance of Lactate Test
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Most Recently Shared on June 15, 2010 at 3:25 pm By:
FDA Clearance of Lactate Test http://ff.im/-m6g7s
BD GBS Assay Receives FDA Clearance, CLIA Moderate Complexity Test Categorization | IVD Technology
ivdtechnology.com — “BD (Becton, Dickinson and Company) announced FDA clearance of the BD MAX Group B Streptococcus (GBS) Assay and Clinical Laboratory Improvement Amendments (CLIA) moderate complexity test categorization on the second-generation BD MAX System. The BD MAX GBS Assay is an IVD test for the detection of GBS DNA in Lim Broth cultures, enabling laboratories to comply with the 2010 CDC guidelines for GBS screening.” View full resource at ivdtechnology.com
Most Recently Shared on March 28, 2012 at 5:09 pm By:
IVD Technology Health Magazine
BD GBS Assay Receives FDA Clearance, CLIA Moderate Complexity Test Categorization http://t.co/rekNPxGo
Bioline Receives Clearance for Streptococcus Molecular Test | IVD Technology
ivdtechnology.com — “Bioline, a wholly-owned subsidiary of Meridian Bioscience Inc., has received clearance from the Therapeutic Goods Administration (TGA) for its illumigene Group B Streptococcus (GBS) test, the newest molecular product on the illumigene platform. The approval in Australia for the commercialization of illumigene GBS comes on the heels of the recent FDA clearance in the United States.” View full resource at ivdtechnology.com
Most Recently Shared on March 21, 2012 at 7:08 pm By:
IVD Technology Health Magazine
Bioline Receives Clearance for Streptococcus Molecular Test http://t.co/7gGf3Jtx
CareFusion's Viking on Nicolet EDX Gets U.S. Clearance
medgadget.com — “CareFusion received 510(k) clearance from the FDA for its Viking on Nicolet EDX electrodiagnostic system. The system can be used for a number of tests li” View full resource at medgadget.com
Most Recently Shared on March 20, 2012 at 11:19 pm By:
[News] CareFusion’s Viking on Nicolet EDX Gets U.S. Clearance http://t.co/jHEyVMJq #medicaldevice
FDA proposes lower risk classification for certain tuberculosis tests
fda.gov — “The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis (TB). This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.” View full resource at fda.gov
Most Recently Shared on March 16, 2012 at 1:37 pm By:
eyeonfda Pharma and Health Lawyer
#FDA proposes lower risk classification for certain tuberculosis tests http://t.co/dfd31Bnw
Roche Receives FDA Clearance for Blood Glucose Monitoring System | IVD Technology
ivdtechnology.com — “Roche has received clearance from FDA for its ACCU-CHEK Nano SmartView blood glucose monitoring system. The new ACCU-CHEK Nano meter, which is smaller than a standard credit card, employs a large brilliant backlit display and does not require any manual coding or code key for enhanced ease of use. It also offers improved functions such as customizable test reminders, pre- and postmeal markers and average glucose calculation.” View full resource at ivdtechnology.com
Most Recently Shared on January 12, 2012 at 7:19 pm By:
IVD Technology Health Magazine
Roche Receives FDA Clearance for Blood Glucose Monitoring System http://t.co/cuv1HA55
LipoScience Submits 510(k) for Nuclear Magnetic Resonance-Based Diagnostic | IVD Technology
ivdtechnology.com — “LipoScience Inc., a North Carolina-based diagnostic company that utilizes nuclear magnetic resonance (NMR) technology in clinical tests, announced that it has submitted the Vantera Clinical Analyzer and the NMR LipoProfile test to FDA for 510(k) clearance. If cleared, Vantera would become the first clinical diagnostic platform based on NMR commercially available for IVD use, the company says.” View full resource at ivdtechnology.com
Most Recently Shared on January 6, 2012 at 10:03 pm By:
IVD Technology Health Magazine
LipoScience Submits 510(k) for Nuclear Magnetic Resonance-Based Diagnostic http://t.co/thrr3D8w
BD Flu Detection System Receives 510(k) Clearance, CLIA Waiver | IVD Technology
ivdtechnology.com — “BD (Becton, Dickinson and Company) received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from FDA for the BD Veritor System for rapid detection of Flu A+B. This is the first rapid influenza test system that incorporates a digital read out of results to receive CLIA waiver.” View full resource at ivdtechnology.com
Most Recently Shared on December 19, 2011 at 4:11 pm By:
IVD Technology Health Magazine
BD Flu Detection System Receives 510(k) Clearance, CLIA Waiver http://t.co/PxkV3eBB
Meridian Bioscience Receives FDA Clearance for Molecular Test | IVD Technology
ivdtechnology.com — “Meridian Bioscience Inc. (Cincinnati) has received FDA clearance for a new molecular diagnostic test for Group B Streptococcus (GBS) on the illumigene platform. This test is a strong addition to the illumigene platform. Group B Streptococcus, or GBS, continues to be a major perinatal pathogen, for both mothers and their infants, and is associated with significant morbidity and mortality.” View full resource at ivdtechnology.com
Most Recently Shared on December 12, 2011 at 6:03 pm By:
IVD Technology Health Magazine
Meridian Bioscience Receives FDA Clearance for Molecular Test http://t.co/dWnoyFae
Abbott receives 510(k) clearance for AML test | IVD Technology
ivdtechnology.com — “Abbott announced earlier this week that it has received 510(k) clearance from FDA for a new genetic IVD test to aid in determining the prognosis of patients with acute myeloid leukemia (AML).” View full resource at ivdtechnology.com
Most Recently Shared on October 28, 2011 at 10:57 pm By:
IVD Technology Health Magazine
Abbott receives 510(k) clearance for AML test http://t.co/lQWJtT6F
Abbott's Genetic Test For Acute Myeloid Leukemia Prognosis Cleared By FDA
medicalnewstoday.com — “Abbott (NYSE: ABT) announced it has received 510(k) clearance from the U.S. Food and Drug Administration for a new in vitro diagnostic test to aid in determining the prognosis of patients with acu” View full resource at medicalnewstoday.com
Most Recently Shared on October 28, 2011 at 9:05 am By:
Abbott's Genetic Test For Acute Myeloid Leukemia Prognosis Cleared By FDA http://t.co/n6PPrUUb #lymphoma #leukemia
Two Influenza test kits receive FDA clearance for use in JBAIDS
news-medical.net — “Last week, the U.S. Army Office of the Surgeon General received Food and Drug Administration (FDA) clearance of two Influenza test kits for use on the Joint Biological Agent Identification and Diagnostic System.” View full resource at news-medical.net
Most Recently Shared on September 30, 2011 at 5:14 am By:
Two Influenza test kits receive FDA clearance for use in JBAIDS: Last week, the U.S. Army Office of the Surgeon ... http://t.co/q4PJ9zKk
Nexera to submit amended claims for FDA 510(k) clearance of SpectraShield 9500 Surgical N95 Respirator
news-medical.net — “Nexera Medical, Inc., today announced plans to submit to the U.S. Food and Drug Administration amended antimicrobial claims for its current 510(k) clearance for the SpectraShield 9500 Surgical N95 Respirator with embedded antimicrobial technology. The expanded antimicrobial claims will be supported by test data on the inactivation performance of certain strains of viruses.” View full resource at news-medical.net
Most Recently Shared on September 8, 2011 at 1:46 pm By:
Bird Flu News: Nexera to submit amended claims for FDA 510(k) clearance of SpectraShield 9500 Surgical N95 Respi... http://t.co/K1NArKK
Combination of blood tests and ROMA algorithm receives FDA clearance to treat ovarian cancer
news-medical.net — “Approval last week by U.S. Food and Drug Administration (FDA) clears the path for nationwide use of tools that show the greatest specificity in estimating the risk of ovarian cancer in women with a pelvic mass.” View full resource at news-medical.net
Most Recently Shared on September 7, 2011 at 2:00 pm By:
Combination of blood tests and ROMA algorithm receives FDA clearance to treat ovarian cancer: Approval last week... http://t.co/wcyzE3E
Combination of blood tests and ROMA algorithm receives FDA clearance to treat ovarian cancer
news-medical.net — “Approval last week by U.S. Food and Drug Administration (FDA) clears the path for nationwide use of tools that show the greatest specificity in estimating the risk of ovarian cancer in women with a pelvic mass.” View full resource at news-medical.net
Most Recently Shared on September 7, 2011 at 8:46 am By:
Combination of blood tests and ROMA algorithm receives FDA clearance to treat ovarian cancer: Approval last week... http://t.co/n2T4wqX
Fujirebio Diagnostics receives FDA 510(k) clearance for Risk of Ovarian Malignancy Algorithm test
news-medical.net — “Fujirebio Diagnostics, the industry leader in oncology biomarker assays, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the company's HE4 Test in an algorithm called ROMA (HE4 EIA + ARCHITECT CA 125 II) to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery.” View full resource at news-medical.net
Most Recently Shared on September 7, 2011 at 8:02 am By:
Ovarian Cancer News: Fujirebio Diagnostics receives FDA 510(k) clearance for Risk of Ovarian Malignancy Algorith... http://t.co/5Y1Iats
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