Diagnostic Substances Company for Sale in Hemet, United States

COMPANY PROFILE.

A World of Excellence in In-Vitro Diagnostic Kits & Reagents.

Has a history of over 36 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. 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 it has three international branches (India, China, and Latin America) and a worldwide distribution network. 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. 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. 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 company 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, Fertility, 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 Glycosometer, 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 Glucose meters + 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, BioFast COVID-19 Assays (BioFast COVID-19 Antigen Test - (Professional Use Only), BioFast COVID-19 Antigen Home TestBioFast COVID-19 Antibody Test, BioFast iAMP COVID-19 Detection Test Kit (Multiplex Fluorescent Detection) BioFast COVID-19 Antigen (Saliva) Home Test* COVID-19 IgG/IgM Antibody Test* COVID-19 IgG/IgM Antibody Test with LF Reader* COVID-19 IgG-only Antibody Test* COVID-19 & M. pneumoniae IgG/IgM Antibody Combo Test* COVID-19 & M. pneumoniae IgG-only Combo Test* COVID-19 and Influenza A/B Antigen Combo Rapid Test* COVID-19 Antigen (Saliva) Test Strip}, *SARS-COV-2 RT-qPCR Assay.

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 Glycosometer + 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. Syphilis 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. COVID- 19 Multiplex PCR Detection.

Selling Features.

Brief Overview:

Globally known with history of over 38 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 and 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 biotechnology. Products were developed, designed, and produced with unique formulations using state-of the-art technology using GMP rules and regulations of FDA and are marketed in, and legally exported from, the USA. It has been certified as a GSA US Federal Vendor and has also the OFAC License.

Goodwill:

Globally known with38 history of US established and US FDA establishment in the field of Lab Medicine,

Intellectual Wealth:

510 (K) s, with Master formulation (own 26 & access to 120)

Technical Files with comprehensive updated performance data and formulations to manufacture and for eligibility for European CE Mark cortication and US FDA 510 (K) pre-filings in Chemistries, Immunochemistry (ELISA &CLIA), Urine Reagent Test Strips, Serologies, Rapid Diagnostics Tests, Veterinary lab Tests, Radio Immuno Assays (RIA) and others. Turn Key Projects in manufacturing of Microbiology Products Lines and others.

Physical assets include own manufacturing plant, machinery, equipment and inventory.

Intangible assets include OFAC license, master formulations, technical files, trademark, good will, global name and more.

Own facility, which is a single story building with 1/4 acre parking space, located on Palm Avenue, Hemet.

Self funded business.

This is a family run business.

There is one owner.

No outstanding loans or liabilities.

The owner is the president of the company.