Company Background
Mr. Kenneth Kupits and Mr. Vincent LaStella founded Immunostics, Inc. in 1983 in Metuchen, NJ to provide clinical laboratories with quality microbiological, serological and immunological reagents and in vitro diagnostic test kits. Working closely with a community of professionals highly skilled in designing and developing diagnostic reagents and testing formats, Immunostics has become a recognized leader in developing innovative and cost effective test systems world wide.
In 1989, the company moved into its current office and laboratory facility with over 6,000 Sq. Ft. in Ocean, NJ. To meet our increasing sales demands, we have expanded our fecal occult blood test kit manufacturing, assembly and inspection areas. We are presently in the process of creating a state of the art lateral flow device production area. Additionally, we have increased our warehousing capacities and now occupy over 13,000 Sq. Ft. in three buildings, with plans to build a 15,000 Sq. Ft. addition in the coming year.
At A Glance
We employ over 40 people with 7 professional level scientists and manufacturing engineers each with over 25 years experience in the design, development, manufacturing and marketing of in vitro diagnostic products.
Our product line includes over 30 products in four clinical areas: pregnancy testing, infectious and autoimmune testing, fecal occult blood testing (FOBT) and direct bacterial identification systems. Messrs. Kupits and LaStella were the originators of the first fecal occult blood slide test, Hemoccult, which was eventually sold to Smith Kline. Immunostics has enjoyed significant growth over the years through timely and innovative product developments. Please see our current product listing attached.
Product Launches & In The Works
Hema-Screen™ EZ-WIPE, the most user-friendly and convenient Guaiac test on the market. Hema-Screen™ CONFIRM, a rapid two-tiered approach for the testing of fecal occult blood utilizing the guaiac method and the option to test specifically for human hemoglobin using the same fecal specimen with our immunochemical test.
Our current product development projects include two innovative redesigned FOB test formats, Urine Sticks for the analysis of creatine, nitrites, pH, glutaraldehyde, etc., High Sensitivity CRP test for coronary disease markers, and line of secondary reference standards for serology, tumor markers, drugs of abuse and coronary markers.
Our Commitment to Quality
The nature of our business demands that we provide the highest quality products and services to our customers. Towards this end, Immunostics has established a comprehensive quality assurance system that meets all the requirements of the ISO 13485:2003 for medical devices, and with overall respect to the statues of US FDA 21 CFR §820 Quality System Regulations and the Canadian MDR. We continue this strong commitment to maintaining the highest standards in the industry.
Over the years we have developed OEM relationships with major manufacturers such as Inverness Medical, Merck, PSS, and Fisher Scientific; and distributors such as Henry Schein, VWR International, & Diagnosphere BioControl. Our sales have increased an average of over 20% for the past few years as marketing and purchasing groups such as ALPHA LABORATORIES (UK), FUMOUZE DIAGNOSTICS (FRANCE), IMCO, LABSCO, PSS, INFOLABS and Allegiance/Cardinal Health & Family Health Planning have picked up our product lines.
In summary, we at Immunostics are poised to meet your marketing needs and look forward to working with you, as with all of our customers, to provide a consistently high quality product backed by unsurpassed customer service and product support.
