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615 N. Palm Avenue
Hemet, CA 92543,USA
United States of America, California
Toll free: 800 595 8766
Phone: 951 658 7766 Fax: 951658 7999 E-Mail:
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Description:
A World of Excellence in in-vitro Diagnostic Kits & Reagents Biotron Diagnostics Inc., formerly known as Nuclear Diagnostics Inc., and Sterling Biochemical Inc., has a history of over 30 years in successfully developing, designing, producing, and marketing a complete line of diagnostics reagents and kits for use in Hospitals, Medical Laboratories, Research Institutions and the Health Care and Pharmaceutical Industries. Its strength stems from a foundation of knowledge experience in quality product development and cost effectiveness in the medical technology field. History Biotron Diagnostics Inc., formerly known as Nuclear Diagnostics Inc., and Sterling Biochemical Inc. has a history of over 35 years in successfully developing, designing, producing, selling and marketing a complete line of diagnostics reagents and kits for use in Hospitals, Medical Laboratories, Research Institutions within the Health Care and Pharmaceutical Industries. Its strength stems from a foundation of knowledge and experience in product development with a commitment to quality and cost effectiveness in the biotechnology field. Biotron Diagnostics Inc.’s products are developed, designed and produced with unique formulations using state-of the-art technology. All in-vitro diagnostics reagents and kits are produced using GMP rules and regulations of the USA FDA. Products are marketed in, USA and Globally. Presently Biotron Diagnostics Inc. has three international branches (India, China, and Latin America) and a worldwide distribution network. Mission Biotron Diagnostics’ main Mission is to produce and distribute USA Made and FDA approved IVD Kits and Reagents globally. OEM, Private Label, Bulk Reagents/Components, CRO and Technology Transfer Services are available. Presently Biotron Diagnostics Inc. has three international branches (India, China, and Latin America) and a worldwide distribution network. Prestigious Clients We are very proud of our high quality FDA approved product lines, particularly , which are currently being sold to institutions such as: CDC, NIH, Prestigious Universities, Research Centers, Cancer Research Institutions, VA and other Prestigious Private Hospitals. Biotron Diagnostics has been certified as a US Government Supply Administration Federal Vendor. Products are competitively priced. Services Offered Biotron Diagnostics’ main mission is to produce and distribute high quality and low cost USA Made and FDA approved IVD Kits and Reagents, offering OEM Service, Private Label, Bulk Reagents/Components, and IVD Technology Transfer in the field of Laboratory Medicine. Current Licenses: FDA Registered Establishment CFG- Free Sale (Current) California PHFDA IVD Manufacturing ISO 13485-2016 (IAS) CE Mark Certified 510(K)s 120 C FG= List of FDA approved IVD Kits City of Hemet Products Summary Biotron Diagnostics develops, produces, provides OEM services and distributes high quality and low cost in vitro diagnostics kits and reagents for Clinical Chemistry (Routine and Research chemistries - similar to Sigma and ultra-sensitive Sickle Cell Kits & Controls)), Immunochemistry (ELISA/CLIA), Urinalysis, Serology ,Fertilit, Coagulation, Blood Banking, Rapid Diagnostics, Drug Screening, Biomarkers (Tumor Markers and Cardiac Tests), Infectious Diseases Rapid Tests (Export only), Bulk Clinical Chemistry & Coagulation Reagents for Instruments, Calibrators, Controls & Standards, Diabetes (Dr. G Glucosemeter & Test Strips ( Dr. G Smart 1, Dr.G Smart 2 , Dr.G Smart 3 )Hematology (Buffers & Reagents), Microbiology (Media, Stains and Reagents), Histology and Cytology (Buffers & Reagents), Veterinary test kits and Petnostics and Molecular Diagnostics (Genomics) Innovated Gene Testing Assays for Cancer and Infectious Diseases. Most Popular & Best Seller Popular Products include advanced Sickle Cell Kit and Sickle Cell Controls (Sensitivity correlates with Hemoglobin Electrophoresis), Biotin-Streptavidin Technology based ELISA Kits, Most advanced UroFast Urine Reagent Test Strips, Dr.G Gluccisemeter , Research Chemistries ,Infectious Disease Rapid Tests for Export, and Temperature Stable Culture Media (up to 60°C). Specialty Products includes ultra-sensitive tests for Fertility ( Novel Pregnancy Test and Male Fertility ), Dr. G Glucosemeters + HBA1C), Serology ( Rubella, SLE, ANA, RPR, FOB, Staph A, Strep A, Febrile Antibodies Kits: febrile Kit, Widal Kit 400 , Widal Kit 800, Rose Bengal Kit, Dri.Dot Kits and H Pylori), Highly Sensitive Infectious Disease Rapid Tests (Strips & Cards) for for Export only (CE Mark ,WHO) for Hepatitis , Human Immunodeficiency Virus 1+2, Treponema Pallidum, Neisseria Gonorrhoeae, Helicobacter Pylori, Malaria, Cholerae Vibrio Antigen (Ogawa/Inaba), Yesinia Pestis, Plague, Tuberculosis, Adenovirus, Rotavirus, A Streptococcus, Chlamydia Trachomatis, Procalcitonin test, Salmonella Typhi, Dengue Virus, Chagas, Zika Virus , and Precise Biomarkers (CEA, FOB, AFP, PSA, Fatty Acid, Troponin I, CK-MB, Myoglobin, C-reactive Protein, Molecular Diagnostics (HPV. Fifteen high-risk types Kits both in multiplex and genotyping formats, Chlamydia Trachomatis, Clostridium Difficile, Coxiella Burnetii, Neisseria Gonorrhoeae, Yesinia Pestis, Bacillus Anthracis, Francisella Tularensis, Haemophilus, Legionella, Listeria, Salmonella, Staphylococcus and Trichomonas Vaginalis), Immunofluorescent Assays ( infectious Diseases —Chagas, Toxplasmosis, Hidatidosis, Syphilis, Triquinosis, Chlamydia trachomatis, Autoimmune Diseases- Anti-DNA, ANAHEp-2, AMA, ASMA, APCA, ANA, LMK, EMAIgA0) and Plasma Proteins RID- human proteins, Combo Immunoglobulins (IgA, IgG, IgM) IgA,IgG,IgM, IgD, Complement C-3 and C-4 and others and Bio-Defense related test assays are researched, developed ,formulated and Produced. Newest Products)includes: 1. 25(OH) Vitamin D ELISA (VDSP) 2. Active Vitamin B12 EIA 3. Urofast URS Reagent Test Strips 11 parameters 4. HPV DNA PCR Detection Kit 5. H. pylori Antigen feces ELISA 6. D r. G Gluciosemeter + HbA1C Combo Meter 7 Allergy Screen 8. Ds DNA ELISA 9. Immune Health IgG ELISA 10. HIV ½ Ag/Ab 4th Generation Rapid Test 11. Calprotectin Rapid Test 12. ANA Screen IgG ELISA 13. . Zika IgM Rapid Test 14. Chikungunya IgM Combo Rapid Test 15. Chlamydia Ag Rapid Test 16. Sphilis Rapid Test 17. Influenza A/B Rapid Test 18. COVID-19 R T(Antigen) both professional and do yourself home test 19. COVID- 19 RT (Antibody) 20. CO VID- 19 Multiplex RT PCR Detection Company Officers Sharan D. Dominguez M.D. Anita J. Gagneja Dr. G L Gagneja Rudy Dominguez Jim Kemp Executive Vice President COO President Director Latin America Sales Director ----------------------------------------------------------------------------------------------------------------Biotron Diagnostics Inc. , 615 N. 615 N Palm Ave., Hemet, CA 92543 Tel: (951) 658-7766; Fax: (951) 658-7999; WhatsApp: 9513579635
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Last update of this entry: May 03, 2023
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