Profile: Focus Diagnostics, Inc. develops & markets quality services for rare, unusual and emerging infectious & immunologic diseases. We are an ISO 13485 certified company. We offer products like HerpeSelectr, DxSelectT kits & IFA/IHA kits. We provide an array of specialized testing services, diagnostic products and anti-infective surveillance & consultative services oriented to the diagnosis, treatment & management of infectious diseases. It includes products for 17 infectious diseases available in a variety of configurations ranging from FDA-cleared kits to analyte specific reagents.

FDA Registration Number: 2023365

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• 11-keto Testosterone EIA Kit

• Alanine Aminotransferase Testing Kit

• Alcohol (Ethanol) Saliva Test Kits

• Allergy Blood Test Kit

• Allergy Patch Test Kit

• Allergy skin Test Kit

• Alpha Fetoprotein Test Kit

• Amines Test Kits

• ANA Test Kit

• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020) Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:

• Anaplasma phagocytophilum IFA IgG Substrate Slide

• Anaplasma phagocytophilum IFA IgM Substrate Slide

• Anti-MPO - ELISA (P-ANCA)Testing Kit

• Anti-MPO ANCA EIA Auto-Immune Markers Testing Kit

• Anti-Myeloperoxidase ELISA Testing Kit

• Arbovirus Test Kits

• Aspergillus Test Kits

• Aspergillus Test Kits, Aspergillus EIA

• Auto LDL-Cholesterol, automated analyzer test kits

• B.Pertussis Antigen (FDA Code: GOX / 866.3065)

• B12/Folate testing Kit

• Bio-Intact PTH Testing Kit

• Bladder Cancer Kits

• Bladder Cancer Testing kits

• Bladder Tumor Antigen (NMP22) Test Kits

• Chlamydia Microplate Immunoenzymatic Test Kits

• Chlamydia Spp Fluorescent Antisera (FDA Code: LKI / 866.3120) Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

• Chlamydia Test Kits

• Cholesterol Home Testing Kits

• cholesterol self-test kit

• Cholesterol Test Kits

• Cholesterol Testing and Cholesterol Monitoring Kits

• Clostridium difficile Test Kits

• Coccidioides Immitis Enzyme Linked Immunoabsorbent Assay (FDA Code: MIY / 866.3135)

• Creatine Kinase Testing Kit

• Creatinine Test Kit, enzymatic

• Creatinine Test Kit, liquid reagents

• Cryptosporidium Spp. (FDA Code: MHJ / 866.3220)

• Cytomegalovirus (CMV) Test Kits

• Cytomegalovirus IgM ELISA Test Kits

• Dehydroepiandrosterone Sulfate Testing Kit

• Detection And Identification Nucleic Acid Or Antigen 2009 H1n1 Influenza Virus (Swine Origin) (FDA Code: OQW / 866.3332)

• Detection And Identification Nucleic Acid Or Antigen 2009 H1n1 Influenza Virus (Swine Origin) Reagents (FDA Code: OPU)

• DHEA-S EIA Reproductive Markers Testing Kit

• Diabetes and Obesity Testing, IA-2 Autoantibody kit

• Diagnostic Kits and Reagents, Ovulation Fern Test Kits

• Diagnostic Test Kits For Pregnancy

• Discrete Photometric Chemistry Analyzer (FDA Code: JJE / 862.2160) A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

• Drug and Alcohol Test Kits

• Drug Testing Kits