Profile: Wampole Laboratories, a wholly owned subsidiary of Inverness Medical Inc., provides diagnostic testing & automation solutions for the clinical laboratory & point-of-care markets. Our full product line includes brands such as the AtheNA Multi-Lyte® test systems for clinical diagnostic testing and clearview point-of-care tests. We face the challenges by today's clinical laboratory and are dedicated to providing accurate and cost-effective diagnostic solutions across a broad test menu including autoimmune, infectious and enteric diseases, STDs, bladder cancer and cardiac risk. From technologically advanced platforms like the AtheNA Multi-Lyter Test system, a breakthrough in simultaneous, single-well, multiple-analyte testing, to one of the industry's most extensive selections of ELISA, IFA, serology and gel diffusion test kits and automation, we offers a full line of products and services to meet your laboratory's clinical diagnostics needs.

The company was founded in 2002, has revenues of USD 10-25 Million, has ~80 employees.

FDA Registration Number: 9710052
US Agent: Golden Jackie / Avo Dental Supplies Llc D/b/a Goldendent Llc
Phone: +1-(586)-585-1210  E-Mail:

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• Anti-SM-Antibody (FDA Code: LKP / 866.5100) An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjogren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

• Antinuclear Antibody, Indirect Immunofluorescen (FDA Code: DHN / 866.5100)

• Autoimmune Test Kits

• Blood Culture Test Kits

• C-Reactive Protein Test System (FDA Code: DCN / 866.5270) A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

• Calibrators

• Campylobacter Pylori (FDA Code: LYR / 866.3110)

• Carcinoembryonic antigen (CEA)

• Carcinoembryonic Antigen Kits

• Carcinoembryonic Antigen Rapid Test Strip

• Cardiac Markers

• Chemistry Analyzers

• Chlamydia Group Enzyme Linked Immunoabsorbent Assay (FDA Code: LJC / 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

• Clinical Immunochemistry Analyzers

• Clostridium Difficile Antigen (FDA Code: MCB / 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.

• Clostridium difficile Test Kits

• Controls

• Controls for Diagnostic Equipment

• Cryptococcus Neoformans Positive Control Antigen Test (FDA Code: JWK / 866.3165)

• Cytomegalovirus (CMV) Test Kits

• Cytomegalovirus Virus IF Antibody Igm Test (FDA Code: LKQ / 866.3175) Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.

• Diagnostic Test Kits For Pregnancy

• Digoxin Calibrators

• Drugs Of Abuse Test Kits

• Drugs Of Abuse Testing Kits

• Early Pregnancy Testing Kit

• Entamoeba Histolytica Antigen (FDA Code: KHW / 866.3220)

• Enzyme Immunoassay

• Epstein-Barr Virus (EBV) Test Kits

• Epstein-Barr Virus IF Antibody IGM (FDA Code: LJN / 866.3235) Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).

• Fecal Occult Blood Test

• Fecal Occult Blood Test Kits

• Fecal Occult Blood Testing Kit

• Fertility Monitors, Pregnancy Test Kits

• Fluorescent Antibody for FTA-ABS Test Antiserum (FDA Code: GMX / 866.3830)

• Free Or Complexed Prostate Specific Antigen (PSA)

• Free Prostate Specific Antigen (PSA)

• FTA-ABS Test Anti-Human Globulin (FDA Code: GMS / 866.3830)

• Gastric and Fecal Occult Blood Test

• General Diagnostic Supplies

• General Diagnostics

• General Examination Supplies

• General Medical Supplies

• Giardia Spp. (FDA Code: MHI / 866.3220)

• H. Pylori Test Kits

• Hematocrit Analyzers

• Hematology Kits

• Hemoglobin and Hematocrit Measurement Calibrator (FDA Code: KRZ / 864.8165) A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.

• Herpes Simplex Virus (HSV) Test Kits