Medical Supplies

13200 Gregg Street
92064 Poway, CA
USA

Phone: (+1-858)5133888
Fax: (+1-858)5138388
http://www.alfascientific.com
info@alfascientific.com

Company Contacts
Department/ Name Address

Product Development Chai Bunyagidj
chai@alfascientific.com

Sales Angela Shen
ashen@alfascientific.com

Company Figures
Number of employees 50-99
Sales volume 1-9 Mio US $
Export content max. 50%
Year of foundation 1996
Area of business Diagnostics

Language: German Language: English Company Profile

About us
ALFA Scientific Designs, Inc. develops and manufactures high quality rapid in-vitro diagnostic devices to serve the point-of-care marketplace including hospitals, physicians, criminal justice, and occupational health centers. We focus on rapid immunoassays including those for the detection of drugs of abuse, fertility hormones, infectious diseases, cardiac and cancer markers. ALFA is committed to satisfying customer’s needs by ensuring the highest level of performance of every device we manufacture.

In less than ten years since its founding in 1996, ALFA has developed over forty-six products most of which are FDA cleared and European CE marked. Moreover, we have twelve patent applications in the USA and in Europe; four of them have been published and eight are pending. Our manufacturing facility is located in beautiful sunny southern California, USA - just northeast of the city of San Diego. We are a California-licensed, cGMP compliant, ISO 13485 registered manufacturer of in-vitro diagnostic devices.

We are actively involved in state-of-the-art R&D initiatives designed to keep our customers at the forefront of diagnostic technology. We strive to inspire their loyalty by providing high quality, easy-to-use test devices at truly affordable prices. We have a comprehensive family of high-quality key products in cassette and dip strip format. Additionally, we offer a variety of services to the medical device industry, including OEM arrangements, product development, custom assembly, and packaging with private labeling.

US Manufacturer of in-vitro rapid diagnostic devices designed for
the detection of drugs of abuse, fertility, cardiac markers, cancer markers and infectious diseases. Alfa is cGMP compliant, US FDA licensed, ISO13485:2003 certified. All products are made in USA. We have 50 products that are FDA 510(k)-cleared and CE-marked.

Product Information
03.02.11 Drugs of abuse / Toxicology

03.02.15 Rapid tests - Immunochemistry

03.02.15.01 Pregnancy tests

03.02.15.02 Infectious desease tests
INSTANT-VIEW ® H.pylori TESTS

• Sensitivity: 95.1%

• Results in 2 to 7 minutes

• Available in serum only or serum/whole blood combination

• FDA 510(k) cleared

• CE Certifi ed for sale in European Union

Rapid, lateral fl ow immunoassay intended to detect the presence of IgG antibodies specifi c to

Helicobacter pylori (H. pylori) in human serum or whole blood.