Chembio Diagnostic Systems, Inc. Company Profile

08:28 EDT 21st June 2018 | BioPortfolio

Chembio Diagnostic Systems, Inc. is a US company serving the increasing global demand for rapid tests needed for the effective prevention and treatment of infectious diseases, and other conditions. Chembio’s focus is on developing, manufacturing and marketing tests for the rapid, simple and cost-effective detection of HIV, Tuberculosis (human and veterinary), and certain other Neglected Diseases. Chembio has a proven commitment toward ensuring sustainable supplies of high quality rapid tests to those who need them by using innovative, socially responsible strategies. Chembio Diagnostic Systems, Inc. operates a cGMP/QS (Good Manufacturing Facility/Quality Systems) manufacturing facility that is registered with the US FDA (Food and Drug Administration). The facility includes dedicated cGMP process manufacturing, Quality Control and R&D laboratories. The company manufacturers class II and class III in vitro diagnostic devices. Chembio ’s HIV assays have been incorporated into the World Health Organization (WHO) Bulk Procurement Scheme and the USAID blanket Waiver List which allows them to be procured with US government funds. In 2006, Former President Bill Clinton announced that his foundation’s HIV/AIDS Initiative negotiated new pricing agreements to lower the prices of HIV diagnostics and two antiretrovirals (ARVs). These products and pricing include Chembio’s STAT-PAK™ HIV 1 / 2 Dipstick. The Foundation’s Procurement Consortium currently includes 50 developing countries around the world.


3661 Horseblock Road
New York
United States of America


Phone: 1 631 924 1135
Fax: 1 631 924 6033

News Articles [825 Associated News Articles listed on BioPortfolio]

Chembio, LumiraDx to develop Dx tests for global health threats

Chembio Diagnostics and LumiraDx entered into a collaborative agreement that will involve developing point-of-care diagnostic -More- 

Chembio Diagnostics Announces Agreement with Bio-Manguinhos to Commercialize Point-of-Care Tests for Dengue, Zika and Chikungunya in Brazil

Chembio Diagnostics (Nasdaq:CEMI), a leader in point-of-care (“POC”) diagnostic tests for infectious diseases, today announced the signing of a long-term agreement with Bio-Manguinhos to c...

Chembio announces pricing of $11.2M public offering

A public offering of about 1.8 million shares of common stock was priced by Chembio Diagnostics at $6.75 apiece in hopes of r -More- 

Chembio Diagnostics nets $11.2mm via FOPO

Chembio Diagnostics Inc. (point-of-care tests for infectious diseases) netted $11.2mm through the public offering of 1.78mm common shares at $6.75 each. The company will use the funds for development ...

Chembio prices $12M follow-on

Global Diagnostic Ultrasound Imaging Systems Market Research Report Forecast 2017 to 2022 [Report Updated: 04122017] Prices from USD $2800

Delivery of the Report will take 23 working days once order is placed.The Global Diagnostic Ultrasound Imaging Systems Market Research Report Forecast 20172022 is a valuable source of insightful data ...

FDA clears Topcon's ocular diagnostic instrument

The FDA granted Topcon Medical Systems 510(k) clearance for its DRI OCT Triton Series system, an ocular diagnostic instrument -More- 

Chembio Diagnostics' (CEMI) CEO John Sperzel on Q4 2017 Results - Earnings Call Transcript

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PubMed Articles [2007 Associated PubMed Articles listed on BioPortfolio]

The diagnostic and cellularity yield of reverse bevel versus fork-tip fine needle biopsy.

Two new systems with a novel tip (Procore™ and SharkCore™) have been introduced for ultrasound-guided fine needle biopsy (US-FNB). Direct comparison of the diagnostic yield of these needles in the...

A brief history of polarity in mood and its diagnostic evolution.

We reviewed the historical development of diagnostic nomenclature and classification systems of mood disorders.

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems. Final order.

The Food and Drug Administration (FDA or we) is classifying the reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have det...

Implications of DSM-5 for the diagnosis of pediatric eating disorders.

The aim of the study was to compare the DSM-IV, DSM-5, and ICD-10 eating disorders (ED) nomenclatures to assess their value in the classification of pediatric eating disorders. We investigated the pre...

Hyperspectral imaging of tissue perfusion and oxygenation in wounds: assessing the impact of a micro capillary dressing.

Experimental tests of non-invasive multi- or hyperspectral imaging (HSI) systems reveal the high potential of support for medical diagnostic purposes and scientific biomedical analysis. Until now the ...

Clinical Trials [2967 Associated Clinical Trials listed on BioPortfolio]

Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test

This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of ...

Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population

This study is to establish the clinical sensitivity of the Chembio Diagnostics Systems, Inc. Clearview COMPLETE HIV 1/2 Assay and Clearview HIV 1/2 Stat-Pak Assay (Clearview HIV tests) in ...

Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps

Several novel imaging technologies are currently used for detection and differentiation of colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan (Pentax). ...

Medical Evaluation of Scanner in Coronary Syndrome

Many recent publications have reported encouraging results on diagnostic cardiac multislice CT performance in 1) coronary artery disease, 2) coronary arterial bypass graft potency and 3) i...

Postpartum Immediate Contraception in Cesarean Deliveries-Comparison of Two Intrauterine Systems

To compare two intrauterine systems in order to avoid complications originating from short pregnancy interval and undesired pregnancies in the early postpartum period.

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Human Immuno Deficiency Virus (HIV)
Human Immunodeficiency Virus (HIV), the causative agent of AIDS. The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...

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