SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
Date
of
Report (Date of earliest event reported): September 27, 2007
(September 25, 2007)
CHEMBIO
DIAGNOSTICS, INC.
(Exact
name of registrant as specified in its charter)
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Nevada
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0-30379
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88-0425691
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(State
or other jurisdiction
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(Commission
File Number)
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(IRS
Employer
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of
Incorporation)
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Identification
Number)
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3661
Horseblock Road
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Medford,
NY 11763
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(Address
of principal executive offices)
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631-924-1135
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(Registrant’s
Telephone Number)
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N/A
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM
7.01. Regulation FD Disclosures.
On
September 25, 2007, the Company issued the press release titled “Chembio
Diagnostics Receives ISO 13.485 Certification” included herein as Exhibit
99.1.
ITEM
9.01. Financial Statements and Exhibits
Exhibits.
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99.1
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Press
Release titled
“Chembio
Diagnostics Receives ISO 13.485
Certification”
issued September 25, 2007.
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In
accordance with General Instruction B.2 of Form 8-K, the information disclosed
in Item 7.01 of, and Exhibit 99.1 attached to, this Current Report on Form
8-K
shall not be deemed “filed” for the purpose of Section 18 of the Securities
Exchange Act of 1934, nor shall it be deemed incorporated by reference in
any
filing. This Current Report on Form 8-K does not constitute a
determination of whether any information included herein is
material.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
Date: September 27,
2007 Chembio
Diagnostics, Inc.
By: /s/ Lawrence A.
Siebert
Lawrence A. Siebert
Chief Executive Officer
Chembio
Diagnostics Receives ISO 13.485 Certification
MEDFORD,
N.Y. (September 25, 2007)– Chembio Diagnostics, Inc. (OTCBB:
CEMI) has received certification under ISO 13.485:
2003. ISO (International Organization for Standardization) is the
world's largest developer and publisher of International
Standards. It is comprised of a network of the
national standards institutes of 155 countries, one member
per country, with a Central Secretariat in Geneva, Switzerland, that coordinates
the system. The primary objective of ISO 13485:2003 is to facilitate harmonized
medical device regulatory requirements; in particular, it specifies requirements
for a quality management system where an organization needs to demonstrate
its
ability to provide medical devices and related services that consistently
meet
customer requirements and regulatory requirements applicable to medical devices
and related services. ISO 13.485 is the quality system that is most recognized
throughout the European Community for products seeking a CE
marking. Chembio has engaged a European Notified Body in
connection with its plans to obtain a CE marking for its products.
Lawrence
Siebert, Chembio’s President and CEO commented, “We are proud to add this ISO
certification to our other regulatory achievements which include two U.S.
Food
and Drug Administration approved Premarket Approval Device Applications
(“PMAs”), and a product and facility license from the U.S. Department
of Agriculture for our veterinary tuberculosis tests. As
manufacturing is one of Chembio’s core competencies, this global certification
underscores the quality of our systems and demonstrates our ability to produce
our point-of-care diagnostics for the global markets. We are very appreciative
and proud of the work of our regulatory, quality assurance and operations
teams
that have enabled us to achieve ISO certification.”
About
Chembio Diagnostics
Chembio
Diagnostics, Inc., a developer and manufacturer of rapid diagnostic tests
for
infectious diseases, is on the frontlines of the global battle against the
AIDS
pandemic. The Company has received marketing approval from the FDA for its
SURE
CHECK® HIV 1/2 and HIV 1/2 STAT-PAK™ rapid tests, marketed under the brand name
Clearview® in the U.S. by Inverness Medical Innovations. Chembio also
manufactures rapid tests for veterinary tuberculosis and chagas
disease. In March 2007 Chembio was issued a U.S. patent for the Dual
Path Platform (DPP™), a next-generation lateral flow platform. DPP
has demonstrated significant advantages over currently available lateral-flow
methods, including increased sensitivity, sample flexibility and multiplexing
capabilities. For additional information please visit
www.chembio.com
Forward-Looking
Statements
Statements
contained herein that are not historical facts may be forward-looking statements
within the meaning of the Securities Act of 1933, as amended. Forward-looking
statements include statements regarding the intent, belief or current
expectations of the Company and its management. Such statements reflect
management's current views, are based on certain assumptions and involve
risks
and uncertainties. Actual results, events, or performance may differ materially
from the above forward-looking statements due to a number of important factors,
and will be dependent upon a variety of factors, including, but not limited
to
Chembio's ability to obtain additional financing, to obtain regulatory approvals
for its products in a timely manner and the demand for Chembio's products.
Chembio undertakes no obligation to publicly update these forward-looking
statements to reflect events or circumstances that occur after the date hereof,
or to reflect any change in Chembio's expectations with regard to these
forward-looking statements or the occurrence of unanticipated events. Factors
that may impact Chembio's success are more fully disclosed in Chembio's most
recent public filings with the U.S. Securities and Exchange
Commission.
Contacts:
Company
Contact: Investor
Relations Contacts:
Chembio
Diagnostics,
Inc.
Lippert/Heilshorn & Associates, Inc.
Matty
Arce
Anne Marie Fields (afields@lhai.com)
(631)
924-1135, ext.
123 (212)
838-3777
www.chembio.com Bruce
Voss (bvoss@lhai.com)
(310) 691-7100
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