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Mindray and MedTest announce FDA 510(k) Clearance for the BS-480 Chemistry Analyzer

Sep 4, 2014 - press releases

For Immediate Release:

(Mahwah, New Jersey & Canton, Michigan)  Mindray™ and MedTest jointly announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market and sell the new Mindray™ BS-480 Chemistry Analyzer.  The Mindray™ BS-480 Analyzer meets the testing needs of mid-volume laboratories while offering state-of-the-art features commonly found on large volume analyzers.

The BS-480 Analyzer produces 400 photometric test results per hour, 240 ISE tests per hour with an overall throughput of 560 tests per hour.  Advanced features of the BS-480 analyzer include numerous automatic processes such as Auto-Start-Up, QC, Rerun, Pre-dilution, Post-dilution, ISE Calibration, Probe Cleaning, Reagent Blank Checks and Probe Collision Recovery which provides the laboratory with smooth operational and enhanced workflow efficiencies. 

Finn Li, Ph.D., General Manager, Mindray™ IVD North America, stated:  “We are excited to launch the BS-480 analyzer into the United States laboratory market.  Mindray™ enjoys satisfied customer experiences with this analyzer outside of the US and looks forward to adding US customers to our installed base.  As Mindray™ has grown rapidly in global markets; the commercialization of the BS-480 further enhances our presence in the US in-vitro diagnostic market, enabling us to continue to introduce new and innovative products for the clinical laboratory in the future.”

MedTest is the exclusive US distributor of the BS-480 Chemistry Analyzer including manufacturing and distribution of reagents, calibrators and quality control products for the general chemistry and drugs of abuse testing markets.  Hanjoon Ryu, MedTest’s CEO, stated: “Mid- and mid-high volume laboratories deserve a more integrated service provider who offers innovative instruments with proven quality reagents, superior customer support and recognized economic advantages.  Partnered with the bench-top BS-200 Chemistry Analyzer, the BS-480 Analyzer enables MedTest to offer a unique testing solution for the Integrated Delivery Networks (IDNs) and Group Purchasing Organizations (GPOs) in the United States.  Our solution will provide commutable testing results between the core laboratory and satellite laboratory.  We are delighted to share this announcement with our strategic partner, Mindray™.”

About Mindray™:  Mindray™ is a leading developer, manufacturer and marketer of medical devices worldwide. Mindray™ maintains the global headquarters in Shenzhen, China, the U.S. headquarters in Mahwah, New Jersey and multiple sales offices in major international markets. From the main manufacturing and engineering base in China, Mindray™ supplies through our worldwide distribution network a broad range of products across three primary business segments, namely patient monitoring and life support, in-vitro diagnostic, and medical imaging systems.

About MedTest:  MedTest is a diagnostics company that provides automated, fast, and cost effective blood and urine testing solutions for diabetes, cardiovascular disease, drugs of abuse, pain management and wellness testing.  In June 2013, MedTest acquired Pointe Scientific, a company that has been developing, manufacturing and distributing clinical diagnostic products including clinical chemistry reagents and instruments in the United States and internationally since 1981.

For additional information, please contact:

                                                                                              

Mindray™   MedTest
Finn Li, Ph.D. Debbie Whitehair, MT(ASCP)SC
General Manager, Mindray™ IVD North America    Vice President, Marketing
905-886-0589 Ext. 2158      484-748-1603
Finn.Li@mindray.com     dwhitehair@medtest.com
www.mindraynorthamerica.com       www.medtest.com

                                                                                             

PR-M1112-01   09/14

Optimized Application Released For autoHDL™ and the Beckman AU 400 Analyzer

Aug 11, 2014 - news

The purpose of this advisory is to alert users of the Pointe Scientific autoHDL™ reagent (catalog #: OH945-480) and the Beckman AU 400, that optimized instrument parameters have been released.

The new application will provide optimized performance. The optimization was a revision in the primary and secondary wavelengths utilized. Please review the attached revised package insert and Instrument application reviewing Instrument Parameter settings closely.

When implementing a change in an application, users may notice a slight shift in their quality control data. Please incorporate this Bulletin into your Quality Control files.

For more information, follow this link.

MedTest introduces the Pointe Scientific Cystatin C Reagent

May 27, 2014 - press releases

For Immediate Release:  MedTest Introduces the Pointe Scientific Cystatin C1 Reagent

(Canton, Michigan) – MedTest introduces the Pointe Scientific Cystatin C1 Reagent.  The reagent is a latex-enhanced immunoturbidimetric assay for the quantitative determination of Cystatin C in human serum, heparinized-plasma, or EDTA-plasma. The reagent can be used on many automated clinical chemistry analyzers. The reagent kit with an assay range of 0.2 to 8.0 mg/L shows excellent correlation with other commercially available assays.

Cystatin C is mainly used as a biomarker of kidney function. Unlike creatinine results for estimating glomerular filtration rates (eGFR), Cystatin C is not dependent on age, sex, race, weight or other parameters.  It is widely published to be a better indicator of early kidney damage and can determine more accurately and more quickly any changes in renal function.  Recently, it has been reported that the use of Cystatin C alone or in combination with creatinine strengthens the association between eGFR and the risks of death and end-stage renal disease across diverse populations2.

About MedTest:  MedTest is a diagnostics company that provides automated, fast, and cost effective blood and urine testing solutions for diabetes, cardiovascular disease, drugs of abuse, pain management and wellness testing.  In June 2013, MedTest acquired Pointe Scientific, a company that has been developing, manufacturing and distributing clinical diagnostic products including clinical chemistry reagents and instruments in the United States and internationally since 1981.

For additional information, please visit www.pointescientific.com or contact:

Debbie Whitehair

Vice President, Marketing

484-748-1603

dwhitehair@medtest.com 

1   For Research Use Only in the USA. Not available for clinical human blood testing in the USA

2   Shlipak MG, et al, Cystatin C versus Creatinine in Determining Risk Based in Kidney Function, N Engl J Medicine 2013; 369: 932-43.

PR-C7584-01   05/14 

Announcing the promotion of Jenna Edgar to the position of QA Laboratory Supervisor

Feb 25, 2014 - news

MedTest, a leading global clinical diagnostics company, is very pleased to announce the appointment of Jenna Edgar to the position of Quality Assurance Laboratory Supervisor. Ms. Edgar has served for the past year and a half as a Laboratory Technician. Her promotion is in recognition of her exceptional performance and leadership skills. 

In her capacity as QA Laboratory Supervisor, Jenna will oversee daily laboratory operations and personnel, and lead the team in workflow related to product release and stability testing. "Under Jenna’s leadership, I am confident the QA Laboratory Team will play a major role in meeting MedTest's Quality Assurance needs and requirements, and achieving our growth objectives," said Ron Jamison, Vice President of Technical Operations with MedTest.

Jenna holds a Bachelors of Science Degree and has been an ASCP registered Clinical Laboratory Scientist for over 5 years.  

MedTest DX Introduces a Highly Complex Drug of Abuse Test Menu

Jan 2, 2014 - press releases

Mindray™ BS-200, Poly-Chem® 180, and Open Channel Applications

Canton, Michigan, January 2, 2014 – MedTest DX, A MedTest Company, is pleased to announce the introduction of a broad, highly complex drug of abuse menu for the Mindray™ BS-200 Chemistry Analyzer, the Poly-Chem® 180 Analyzer and as open channel applications on other clinical chemistry analyzers such as the Beckman Coulter AU instrument series in the United States. The introduction of this menu enables MedTest DX to provide high quality drug of abuse reagents to customers focused on pain management and drug abuse testing. 

Mindray™ BS-200 and Open Channel Applications

MedTest DX introduces 16 highly complex, urine drugs of abuse tests that include: 

6-Acetylmorphine, Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine (Suboxone), Cannabinoid (THC), Cocaine Metabolite, Ecstasy (MDMA), Ethanol, Methadone, Methadone Metabolite (EDDP), Methamphetamine, Opiates, Oxycodone, Phencyclidine and Propoxyphene

Poly-Chem® 180

MedTest DX introduces 5 highly complex, urine drugs of abuse tests (6-Acetylmorphine, Buprenorphine, Oxycodone, Phencyclidine and Propoxyphene) to its existing 10 tests that make up the moderately complex test menu.

“Menu expansion enables MedTest DX to meet our customer’s needs in the pain management and drug abuse testing arena” said Hanjoon Ryu, CEO of MedTest.  “Our drugs of abuse offering on analyzers like the Mindray™ BS-200 enable our pain management clinic customers to implement a quality urine screening process while allowing our laboratory customers to minimize their overall cost and enhance their overall efficiency.”

For more information on MedTest DX’s urine drugs of abuse portfolio, please contact Debbie Whitehair at dwhitehair@medtestdx.com, Sales Support at 1.800.445.9853 or visit www.medtestdx.com 

 

PR-M2111-03   12/13

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