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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• Hemoglobin Test Kit system

• Hepatitis B Surface Antibody Test Kits

• Hepatitis B Surface Antigen Test Kits

• Hepatitis C Antibodies (HCV) Rapid Test Kit

• Hepatitis C Antibody Test Kits

• Hepatitis C Test Kit

• Hepatitis Disease Surface Antigen (HBsAg) Test Kits

• Hepatitis-infectious Mononucleosis Antibody Test Kits

• Heroin Drug Test Kits

• Herpes Simplex Virus (HSV) Test Kits

• Herpes Simplex Virus Enzyme Linked Immunoabsorbent Assay (FDA Code: LGC / 866.3305)

• Herpes Simplex Virus Immunoperoxidase Test Kit

• Herpes Simplex Virus-1 ELISA Testing Kit

• Histoplasma Capsulatum Enzyme Linked Immunoabsorbent Assay (FDA Code: MIZ / 866.3320)

• Histoplasma Test Kits

• HIV and H.Pylori testing kits

• HIV Antibody Test Kits

• Home Allergy Test Kit

• Home Drug Testing Kits and

• Home Microalbumin Testing Kit

• Home pregnancy test kits, Hcg

• HSV-1 Herpes Simplex Virus Enzyme-Linked Immunosorbent Assay (FDA Code: MXJ / 866.3305)

• HSV-2 Herpes Simplex Virus Enzyme-Linked Immunosorbent Assay (FDA Code: MYF / 866.3305)

• Infectious Disease Identification Test Kits

• Infectious Disease Testing, Arbovirus IFA IgG

• Infectious Disease Testing, Arbovirus IFA IgM

• Infectious Disease Testing, Q Fever Test Kits

• Infectious Disease Testing, Rickettsia Test Kits

• Legionella Direct & Indirect Fluorescent Antibody Regents (FDA Code: LHL / 866.3300)

• Leptospira Spp Antigen (FDA Code: GRY / 866.3350)

• Leptospirosis IHA Kits

• Leptospirosis Test Kits

• Microbiology Diagnostic Device (FDA Code: LIB / 866.2660) A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

• Midstream Clean-Catch Urine Samples Kits

• Multi-Analyte Controls Unassayed (FDA Code: OHQ / 862.1660) A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

• Mycoplasma Spp. DNA-Reagents (FDA Code: LQG / 866.3375)

• Not Assay Specific Internal Polymerase Chain Reaction Control (FDA Code: OLD / 862.1660)

• Publications

• Publications Service

• Q Fever Fluorescent Antiserum (FDA Code: GPJ / 866.3500) Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genusRickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).

• Q Fever IFA IgG

• Q Fever IFA IgM

• Q Fever Test Kits

• Reference Laboratory Services

• Reference Testing Facilities

• Rickettsia IFA IgG

• Rickettsia Serological Reagents (FDA Code: LSQ / 866.3500)

• Rickettsia Test Kits

• Typhus Fever Antiserum Test (FDA Code: GPN / 866.3500)

• West Nile Virus (WNV) Test Kits