Profile: SA Scientific, Inc. designs, develops & produces a wide range of one-step rapid tests for fertility & infectious diseases. We manufacture products to aid in the detection of pregnancy (hCG), ovulation (hLH) and menopause (hFSH). Our pregnancy products help to detect hCG in either serum or urine in as early as 7-10 days after conception. Our ovulation test is a urine based rapid test that assists the end user to determine the hLH surge during menses. Molecular tests utilize nucleic acid amplification technologies to amplify a DNA or RNA template from a few copies to billions of copies in a short period of time, allowing highly sensitive and specific detection of the targeting organisms. Traditionally, molecular testing is performed using polymerase chain reaction (PCR) technology, which is aided by the heat-stable DNA polymerase or similar enzymes.
The company was founded in 1984, has revenues of USD 5-10 Million, has ~50 employees.
FDA Registration Number: 1645225
43 Products/Services (Click for related suppliers)
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• Adenovirus 1-33 CF Antigen (FDA Code: GOD / 866.3020) Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis). |
• Antibody Detection Candida Species (FDA Code: LSG / 866.3165) |
• Antistreptolysin-Titer/Streptolysin O Reagent (FDA Code: GTQ / 866.3720) |
• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 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. |
• Brucella Spp Agglutination Antigen (FDA Code: GSO / 866.3085) |
• 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. |
• Escherichia Coli Antigens (FDA Code: GMZ / 866.3255) |
• Escherichia Coli Antisera (FDA Code: GNA / 866.3255) |
• Febrile Antigen (FDA Code: GSZ / 866.3410) |
• Fertility Monitors, Pregnancy Test Kits |
• Francisella Tularensis Slide and Tube Antigen Test (FDA Code: GSL / 866.3280) |
• General Diagnostic Supplies |
• Haemophilus Influenza Antiserum (FDA Code: GRP / 866.3300) |
• HCG Over The Counter Pregnancy Test Kit (FDA Code: LCX / 862.1155) A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. |
• Home pregnancy test kits, Hcg |
• Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI / 862.1155) |
• Human Chorionic Gonadotropin Test |
• Id Direct Antigen Candida Spp. (FDA Code: LRF / 866.3165) |
• Infectious Disease Testing, Rotavirus Test Kits |
• Infectious Mononucleosis Test System (FDA Code: KTN / 866.5640) An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis. |
• Listeria Monocytogenes Antisera (FDA Code: GSH / 866.3355) |
• N. Meningitidis Antisera (FDA Code: GTJ / 866.3390) |
• Positive and Negative Febrile Antigen Control Serum (FDA Code: GSN / 866.3085) |
• Pregnancy Test Kit |
• Proteus Spp Fluorescent Antisera (FDA Code: GSY / 866.3410) |
• Reovirus 1-3 CF Antigen (FDA Code: GQB / 866.3470) Reovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to reovirus in serum. The identification aids in the diagnosis of reovirus infections and provides epidemiological information on diseases caused by these viruses. Reoviruses are thought to cause only mild respiratory and gastrointestinal illnesses. |
• Respiratory Syncytial CF Antigen (FDA Code: GQG / 866.3480) Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia. |
• Rheumatoid Factor Test System (FDA Code: DHR / 866.5775) A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. |
• Rotavirus Test Kits |
• Rotavirus Test, Gastroenteritis |
• Salmonella Spp Antigen (FDA Code: GRL / 866.3550) |
• Salmonella Spp Antiserum (FDA Code: GRM / 866.3550) |
• Shigella Spp Antiserum (FDA Code: GNB / 866.3660) |
• Sickle Cell Test (FDA Code: GHM / 864.7825) A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases. |
• Streptococcus Spp Antigen (FDA Code: GTY / 866.3740) |
• Streptococcus Spp Antiserum (FDA Code: GTZ / 866.3740) |
• Streptococcus Test Kits |
• Streptolysin O (FDA Code: IBA / 864.4400) Enzyme preparations are products that are used in the histopathology laboratory for the following purposes: |
• Swabs, Streptococcus Test Kits |
• Syphilis Test |
• Systemic Lupus Erythematosus Test (FDA Code: DHC / 866.5820) A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies). |
• Toxoplasma Gondii IHA Antigen Test (FDA Code: GMM / 866.3780) |
• Vibrio Cholerae Antiserum (FDA Code: GSQ / 866.3930) |