Applied BioCode Announces Exclusive Partner Distribution Agreement with Hardy Diagnostics, Further Broadens Reach of BioCode® MDx-3000 System into Hospitals and Reference Laboratories in the United States

Key Facts

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode today announced an agreement with Hardy Diagnostics, a leader in manufactured and distributed microbiology products in the United States, for the distribution of the MDx-3000 System and its comprehensive menu for the diagnosis of upper respiratory infections, gastrointestinal infections as well as a suite of Analyte Specific Reagents (ASRs) which can be used by high-complexity laboratories to develop their own laboratory developed tests (LDTs).
This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, Influenza A (with H1 pdm09, H1 seasonal, H3 subtypes), Influenza B, and/or Respiratory Syncytial Virus (RSV), not for any other viruses or pathogens.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21.