bioMérieux
Receives FDA Clearance for BacT/ALERT® BPA and
BPN Culture Bottles
St.Louis, MO - January 16, 2006– The United States Food and Drug
Administration (FDA) has given a new 510(k) clearance to bioMérieux
for the BacT/ALERT® BPA and BacT/ALERT BPN culture
bottles. These bottles are used with the BacT/ALERT Microbial
Detection Systems for the Quality Control testing of a pool of
up to six leukocyte reduced random whole blood platelet concentrates
(LRWBPC). The clearance also includes fill volume range adjustment
of 4-10 mL* for all cleared sample types, leukocyte reduced apheresis
platelet (LRAP) units and both leukocyte reduced single and a
pool of up to six units LRWBPC.
About bioMérieux INDUSTRY
bioMérieux INDUSTRY provides product solutions to quality
control and research microbiology laboratories. Applications served
include environmental monitoring, sterility testing, pathogen
screening, quality indicators, microbial identification, in-process
quality control testing, microbial limits and preservative effectiveness
testing.
About bioMérieux
A global leader in disease prevention and management, bioMérieux
provides assays, reagents and instrumentation for clinical microbiology,
coagulation, immunoassay, and nucleic acid diagnostics; and also
for product quality control in the blood bank, agri-food, cosmetics
and pharmaceutical industries. Based in Marcy-l'Etoile, France,
the company's U.S. headquarters is in Durham, North Carolina.
With sales of 1 billion Euros in 2003, bioMérieux ranks
as the eighth-largest biological diagnostics company worldwide.
Over 81% of its activity takes place on an international level.
Investment in research and development represents 13% of sales.
bioMérieux employs 5400 people throughout the world, including
3200 in Europe and 1500 in the U.S. The group has 15 production
sites located in France, the United States, Brazil, Italy and
the Netherlands, as well as a European logistics center in France.
Already present in over 130 countries, with more than 110 distributors
and 32 subsidiaries, bioMérieux continues its international
development by strengthening its presence in Latin America and
Asia.
* For sites releasing 7 day platelets, please
reference the appropriate automated collection company's
website for more details on the fill volume range.
www.gambrobct.com
www.baxter.com
Learn more about
BacT/ALERT 3D
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