Gibson Laboratories Achieves CE Mark Conformity For Tri-Valent Swab
Gibson Laboratories, LLC, announced recently that their Tri-Valent Swab product line has achieved CE Mark conformity with the In Vitro Diagnostic Medical Device Directive 98/79/EC. The Tri-Valent swab is used for quality control testing in the Clinical industry. It is used specifically with the BD Affirm VPIII Microbial Identification System DNA Probe Detection Kit. Each Tri-Valent Swab consists of whole stabilized cells of Trichomonas vaginalis, Gardnerella vaginalis and Candida albicans to function as a tri-analyte swab.
The Tri-Valent swab is specially designed for use with Becton Dickinson's Affirm VPIII Microbial Identification System; specifically with the DNA Detection Kit. The Affirm VPIII Microbial Identification Test is the first direct specimen RNA probe-based diagnostic test for the differential detection and identification of the causative agents for vaginitis including Candida species, Gardnerella vaginalis and Trichomonas vaginalis. The Tri-Valent Swab provides the positive and negative controls to ensure test quality for the DNA Detection Kit.
Obtaining CE Mark Conformity allows the Tri-Valent Swab to be shipped in the European Economic Area. Naomi Bowling, Vice President of Gibson Laboratories, states "Having CE Mark conformity for the Tri-Valent will be a great asset to Gibson Laboratories. We're excited to introduce this unique product line to the global marketplace." Bowling continues, "Clinical laboratories world-wide can use this product easily and efficiently."
In January 2009 Gibson Laboratories became a subsidiary of MicroBioLogics, Inc. The two companies will join forces to market the Tri-Valent Swab internationally. MicroBioLogics currently has a global distribution network of nearly 125 companies servicing approximately 110 countries around the world. Brad Goskowicz, MicroBioLogics Chief Marketing Officer, explains, "There's a lot of potential for the Tri-Valent Swab in the European market. Conforming to CE Mark regulation is critical to successfully launching this product globally."
About Gibson Laboratories, LLC
Gibson Labs has been in the microbiology business for over 30 years. Gibson manufactures a wide range of high quality microbiological products used by clinical, industrial, research and academic laboratories. They provide a full array of microbiology supplies including prepared culture media, stains & reagents, rapid test kits, QC controls, lyophilized bacterial and fungal cultures, fungal serology, and custom manufactured products. The company also does contract manufacturing for several well-known clients. The company is an FDA registered establishment and conforms to CE Mark regulations.
About MicroBioLogics, Inc
MicroBioLogics manufactures cost-effective, reliable, and convenient solutions for Quality Control in microbiology labs. They specialize in manufacturing lyophilized microorganisms for clinical, pharmaceutical, cosmetic, food quality, and environment laboratories. The company is an FDA registered establishment, conforms to CE Mark regulations, has achieved ISO 9001:2000 Certification and is accredited in accordance with ISO/IEC 17025:2005 and ISO Guide 34:2000.
SOURCE: Gibson Laboratories, LLC