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[BioSpectrum News] Underwriters Lab opens facility in Bangalore PDF Print E-mail
Written by Sales Team   

news resource [BioSpectrum]

 

Singapore, Mar 25, 2010: Underwriters Laboratories (UL), the global leader in product safety testing and certification, has opened its first state-of-the-art testing facility in Bangalore, India.
Catering to manufacturers throughout India and the surrounding Asian region, the comprehensive 40,000 square-foot testing facility will offer performance, safety and compliance testing for products and provide global market access services to help reduce time-to-market. The comprehensive laboratory will specialize in product categories including electrical power and controls, appliances, industrial control equipment, lighting, information technology and medical equipment, motors and pumps, and other related categories.
UL invested close to $6 million to set up the 40,000 square-foot facility in India. A unique feature of the facility is that many of the lab capabilities have been designed taking into account specified customer requirements for product performance and developmental testing in addition to safety compliance testing. According to UL, the availability of these facilities in India will reduce the cost and time to market considerably.
“Given the projected growth of the Indian electrical industry for the next decade, Underwriters Laboratories is proud to strengthen its Indian footprint as we strive to provide the best in certification and testing, industry-oriented research and technology development,” said Mr Keith Williams, President and CEO for UL. “Manufacturers throughout India and the emerging markets region are known for the innovation and drive to be globally competitive. It is our hope that this facility will prove to be a growth facilitator and accelerator by testing and certifying products to international standards, ultimately helping them get safer products to market faster anywhere in the world.”
"UL is uniquely positioned in India with the deep technical knowledge and local testing capability to certify products manufactured here and help leverage the potential in the global market,” said Mr RA Venkitachalam, UL’s vice president and managing director of Emerging Markets. ”Being one of the world's largest Conformity Assessment Service Providers and backed by more than 115 years of experience in product testing and inspection, UL routinely assesses more than 19,000 types of products, systems and processes around the world.”

Singapore, Mar 25, 2010: Underwriters Laboratories (UL), the global leader in product safety testing and certification, has opened its first state-of-the-art testing facility in Bangalore, India.


Catering to manufacturers throughout India and the surrounding Asian region, the comprehensive 40,000 square-foot testing facility will offer performance, safety and compliance testing for products and provide global market access services to help reduce time-to-market. The comprehensive laboratory will specialize in product categories including electrical power and controls, appliances, industrial control equipment, lighting, information technology and medical equipment, motors and pumps, and other related categories.


UL invested close to $6 million to set up the 40,000 square-foot facility in India. A unique feature of the facility is that many of the lab capabilities have been designed taking into account specified customer requirements for product performance

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and developmental testing in addition to safety compliance testing. According to UL, the availability of these facilities in India will reduce the cost and time to market considerably.

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“Given the projected growth of the Indian electrical industry for the next decade, Underwriters Laboratories is proud to strengthen its Indian footprint as we strive to provide the best in certification and testing, industry-oriented research and technology development,” said Mr Keith Williams, President and CEO for UL. “Manufacturers throughout India and the emerging markets region are known for the innovation and drive to be globally competitive. It is our hope that this facility will prove to be a growth facilitator and accelerator by testing and certifying products to international standards, ultimately helping them get safer products to market faster anywhere in the world.”


"UL is uniquely positioned in India with the deep technical knowledge and local testing capability to certify products manufactured here and help leverage the potential in the global market,” said Mr RA Venkitachalam, UL’s vice president and managing director of Emerging Markets. ”Being one of the world's largest Conformity Assessment Service Providers and backed by more than 115 years of experience in product testing and inspection, UL routinely assesses more than 19,000 types of products, systems and processes around the world.”

 

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[FDA] Avoiding Glucose Monitoring Errors PDF Print E-mail
Written by Sales Team   

HMD BioMedical use NO GDH-PQQ enzyme for our test strip.

 

Advice for Patients: Serious Errors with Certain Blood Glucose Monitoring Test Strips

Issued: August 13, 2009

 

Informations from FDA, link in here

 

For

Diabetic patients and/or their caregivers

Advice

NEVER use GDH-PQQ* glucose meters or test strips if you are using drug products or therapies that contain certain sugars other than glucose.

*GDH-PQQ stands for glucose dehydrogenase pyrroloquinoline quinone

Issue

Diabetic patients who receive drug products or therapies containing certain sugars other than glucose could experience serious, although rare, injuries if they use blood glucose meters with a particular type of test-strip technology. Strips that use this technology, known as GDH-PQQ, will react with certain non-glucose sugars, including maltose, galactose and xylose, and produce a falsely high (elevated) result. If a diabetic patient then takes too much insulin because of this falsely high result, it could lead to abnormally low blood sugar (hypoglycemia), coma, or even death.

Certain patients may be more likely to be using drug products or therapies that contain other sugars, including those who:

  • are on peritoneal dialysis
  • have recently had surgery

Glucose test strips other than the GDH-PQQ type are not affected by this problem, and can be used by patients taking drug products or therapies that contain non-glucose sugars.

List of GDH-PQQ test strips and their associated meters

List of GDH-PQQ Glucose Test Strips

Drug products or therapies with non-glucose sugars

  • Extraneal (icodextrin) peritoneal dialysis solution
  • Some immunoglobulins: Octagam 5%, Gamimune N 5% **, WinRho SDF Liquid, Vaccinia Immune Globulin Intravenous (Human) and HepaGamB
  • Orencia (abatacept)
  • Adept adhesion reduction solution (4% icodextrin)
  • BEXXAR radioimmunotherapy agent
  • Any product that contains, or the body breaks down into, the sugars maltose, galactose or xylose

** Within the U.S., Gamimune N 5% has not been manufactured since December 2005, and no lots are in distribution

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in the U.S.

 

Patient concerns

If you are taking drug products or therapies that contain certain non-glucose sugars, such as maltose, galactose and xylose, these sugars will produce a falsely elevated glucose result if you are measuring your blood glucose using a GDH-PQQ test strip. If you then use this falsely elevated result to determine your dose of insulin, you could give yourself too much insulin, which could result in dangerously low blood glucose. In addition, if your blood glucose is actually low, it could go unrecognized and untreated because the test result could read higher than it actually is and appear to be within the normal range. In this case, you may not know your blood glucose is low unless you have certain symptoms, including confusion, hunger, nervousness, dizziness, irritability, sweating, heart pounding (palpitations), shaking, unusual fatigue or weakness, or tunnel or darkened vision. Low blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.

Reports received by FDA

From 1997 - 2009, FDA received 13 reports of death associated with

GDH-PQQ glucose test strips in which there was interference from maltose or other non-glucose sugars. The deaths occurred in healthcare facilities. Some reports indicated that serious patient injury, such as low blood glucose (hypoglycemia), confusion, neurologic deterioration, too little oxygen in the tissues (severe hypoxia), brain damage and coma, occurred prior to death.

 

FDA is working with manufacturers to resolve the problems with GDH-PQQ glucose test strips, and is continuing to monitor adverse events associated with these products.

 

Questions to ask your healthcare provider
How do I determine which glucose meter and strips I have?
Which drugs am I currently taking? Am I taking or receiving an interfering drug product or therapy?
Should I continue testing my blood glucose with my current meter and strips or should I get a new meter and strips? If so, how do I do this?
For more information see FDA Public Health Notification: Potentially Fatal Errors with GDH-PQQ Glucose Monitoring Technology.
Reporting adverse reactions
Consumers may report adverse reactions related to glucose meters or glucose test strips to FDA’s MedWatch Adverse Event Reporting Program online, by phone, FAX or mail.
Online: MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Phone: 1-800-332-1088
FAX: 1-800-FDA-0178
Mail: use postage-paid FDA form 3500 mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
List of GDH-PQQ Glucose Test Strips
The following test strips (with associated meters) use GDH-PQQ methodology as of August 2009:
Roche Diagnostics:
ACCU-CHEK Comfort Curve test strips, for use with:
ACCU-CHEK Inform meters [model 2001201]
ACCU-CHEK Complete meters [models 200 and 250]
ACCU-CHEK Advantage meters [models 888, 831, 850, and 768]
ACCU-CHEK Voicemate meters [model 0009221]
ACCU-CHEK Aviva test strips, for use with:
ACCU-CHEK Aviva meters [models 525, 535, and 555]
ACCU-CHEK Compact test strips, for use with:
ACCU-CHEK Compact meters [model GF]
ACCU-CHEK Compact Plus meters [models GP and GT]
ACCU-CHEK Go test strips
ACCU-CHEK Go meters [model GJ]
ACCU-CHEK Active test strips
ACCU-CHEK Active meters [models GG and GN]
Abbott Diabetes Care:
Freestyle test strips, for use with:
FreeStyle meters
FreeStyle Flash meters
FreeStyle Freedom meters
Freestyle Lite test strips, for use with:
FreeStyle Lite meters
FreeStyle Freedom Lite meters
Home Diagnostics:
TRUEtest test strips
TRUEresult meters
TRUE2go meters
Smiths Medical:
Abbott Diabetes Care Freestyle test strips, for use with:
CoZmonitor blood glucose module (for use with the Deltec Cozmo Insulin Pump)
Insulet:
Abbott Diabetes Care Freestyle test strips, for use with:
OmniPod Insulin Management System
Note: Test strips currently on the market may be distributed under multiple trade names. In addition, manufacturers of GDH-PQQ test strips currently on the market may subsequently change to non-GDH-PQQ methodology. Therefore, healthcare providers (and patients) should refer to device labeling or consult with test strip manufacturers to confirm the type of methodology used.

 

List of GDH-PQQ Glucose Test Strips

The following test strips (with associated meters) use GDH-PQQ methodology as of August 2009:

Roche Diagnostics:

  • ACCU-CHEK Comfort Curve test strips, for use with:
    • ACCU-CHEK Inform meters [model 2001201]
    • ACCU-CHEK Complete meters [models 200 and 250]
    • ACCU-CHEK Advantage meters [models 888, 831, 850, and 768]
    • ACCU-CHEK Voicemate meters [model 0009221]
  • ACCU-CHEK Aviva test strips, for use with:
    • ACCU-CHEK Aviva meters [models 525, 535, and 555]
  • ACCU-CHEK Compact test strips, for use with:
    • ACCU-CHEK Compact meters [model GF]
    • ACCU-CHEK Compact Plus meters [models GP and GT]
  • ACCU-CHEK Go test strips
    • ACCU-CHEK Go meters [model GJ]
  • ACCU-CHEK Active test strips
    • ACCU-CHEK Active meters [models GG and GN]

Abbott Diabetes Care:

  • Freestyle test strips, for use with:
    • FreeStyle meters
    • FreeStyle Flash meters
    • FreeStyle Freedom meters
  • Freestyle Lite test strips, for use with:
    • FreeStyle Lite meters
    • FreeStyle Freedom Lite meters

Home Diagnostics:

  • TRUEtest test strips
    • TRUEresult meters
    • TRUE2go meters

Smiths Medical:

  • Abbott Diabetes Care Freestyle test strips, for use with:
    • CoZmonitor blood glucose module (for use with the Deltec Cozmo Insulin Pump)

Insulet:

  • Abbott Diabetes Care Freestyle test strips, for use with:
    • OmniPod Insulin Management System

 

Note: Test strips currently on the market may be distributed under multiple trade names. In addition, manufacturers of GDH-PQQ test strips currently on the market may subsequently change to non-GDH-PQQ methodology. Therefore, healthcare providers (and patients) should refer to device labeling or consult with test strip manufacturers to confirm the type of methodology used.

 

* For further detailed information, please refer to the FDA link.

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[HMD News] See us at Medical Fair India 2010 this year! HMD Booth No.D13 PDF Print E-mail
Written by Sales Team   
Dear Sir,
We shall come to Mumbai on March 12th 2010 to show our Glucose Meter.
Our booth number is D13! You are very much welcome to visit us!
In this exhibition, not only you shall see the personal health glucose meter, but also for the hospital use professional glucose meter.
Our glucose is a patented truly automatic digital coding without sacrificing the accuracy. Not like our competitors who also claim auto coding or no coding, however they sacrifice the accuracy.
In addition to vial package, we present this year the single foil packet.
You shall see all of these in this trade show in Mumbai. Welcome!
Event Name : Medical Fair India 2010 ,16th International Exhibition and Conference on Diagnostic,Medical Equipment and Technology
Exhibition Date : March 12th - 14th, 2010
Exhibition Location : Hall V, Mumbai Exhibition Centre, Western Express Highway,
Goregon (East), Mumbai 200 063, India
HMD Booth Number : D13
Yours Sincerely
Kent FANG

Dear Customers


We shall come to Mumbai on March 12th 2010 to show our Glucose Meter. Our booth number is D13! You are very much welcome to visit us!

 

In this exhibition, not only you shall see the personal health glucose meter, but also for the hospital use professional glucose meter.

 

Our glucose is a patented truly automatic digital coding without sacrificing the accuracy. Not like our competitors who also claim auto coding or no coding, however they sacrifice the accuracy.

 

In addition to vial package, we present this year the single foil packet.

 

You shall see all of these in this trade show in Mumbai. Welcome!

 

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Event Name Medical Fair India 2010
Event website http://www.medicalfair-india.com/
Exhibition Date March 12th - 14th, 2010
Exhibition Location

Hall V, Mumbai Exhibition Centre, Western Express Highway,

Goregon (East), Mumbai 200 063, India

HMD Booth Number D13


Yours Sincerely

HMD BioMedical Inc. Sales Team

 

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[IDF News] BBC World to air diabetes documentary PDF Print E-mail
Written by Sales Team   

IDF_BBC_JC-Mbanya-150pxStarting January 12,

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