General Purpose Reagents & Equipment for the Clinical Laboratory

Promega Corporation proudly supports the Molecular Diagnostics efforts of university, hospital and commercial clinical labs with a long tradition of manufacturing reliability and excellence coupled with expert technical product support.

Promega produces reagents that are used as components or raw materials in the molecular biology applications that customers develop as part of their clinical research programs. These reagents are enzymes, signal detection systems and purified biochemicals that, by themselves, generate no in vitro diagnostic test result whatsoever; when used in combination with other materials and systems provided by the end user, however, they serve as key components within the final in vitro diagnostic test that the customer has designed.

For developers and manufacturers of finished molecular in vitro diagnostic tests, Promega can supply these reagent raw materials as bulk components as part of our Custom Manufacturing business.

Promega provides these kinds of products as general purpose laboratory reagents and simple lab equipment labeled with the intended use statement, “For Laboratory Use.” For product identification in this web site, we use restrictions under the specifications tab on the product pages to indicate this intended use.

Intended Use of Promega Products

Promega Corporation manufactures reagent and instrument products that have multiple intended uses.

Products are labeled for these distinct intended uses:

• For research use;
• For forensic and paternity testing use;
• For use as raw materials in different biochemical and molecular biology applications that customers develop;
• this includes the use of Promega reagent materials as components of a customer’s finished in vitro diagnostic test system;
• this includes the use of Promega reagent materials as quality control tests in pharmaceutical manufacturing processes
• CE-IVD marked accessory medical devices for automated nucleic acid sample isolation
• CE-IVD marked DNA analysis kit

The table below indicates the intended use statement that can appear on the label and related product information. The table further identifies the applicable regulation or guidance that may apply to a manufacturer’s intended use claim.