Shinjin Medics Inc.


Manufacturer and developer of in vitro diagnostic reagents, assay kits and laboratory instruments. Product portfolio includes radioimmunoassay and enzyme immunoassay reagent panels, lateral-flow point-of-care rapid tests (antigen and antibody), PCR detection kits and nucleic-acid preparation reagents, microplate instruments and gamma counters, and automated laboratory workflow systems. The company reports ISO 13485 certification, national GMP recognition, CE/IVD conformity assessments, national device registrations and emergency-use authorizations for selected products.

Industries

Medical Equipment Manufacturing

Nr. of Employees

medium (51-250)

Shinjin Medics Inc.


Products

Radioimmunoassay reagent panels (hormones, tumor markers, infectious serology)

Tube-based radioimmunoassay reagent kits and panels for clinical laboratory measurement of hormones, tumor markers and viral serology; multiple registered product lines and catalog entries documented.

ELISA kits and supporting microplate instruments

Plate-based enzyme immunoassay kits for tumor markers, thyroid/autoimmune markers and infectious serology with supporting microplate equipment (washers, spectrophotometers, incubators) and automation options.

Point-of-care lateral-flow rapid tests

Lateral-flow rapid antigen and antibody tests and multi-analyte rapid panels for decentralized screening and point-of-care use, including respiratory virus antigen tests and infectious-disease serology.

Molecular diagnostic kits and nucleic-acid preparation reagents

PCR detection kits for pathogen identification and viral DNA/RNA preparation/extraction kits for molecular diagnostic sample workflows.

Diagnostic instruments for immunoassay workflows

Instruments supporting RIA and ELISA workflows, including gamma counters, automated dispensers, tube washers, microplate washers, spectrophotometers, incubators and fully automated analyzers for laboratory immunoassay testing and automated processing.

MESSIAH

User-friendly fully automated Gamma Counter system with 5 or 10 detectors, featuring a Windows 7 based touch screen interface and automatic upgrade system.

View All Products

Services

Contract and in-house research, development and manufacturing of immunoassay reagents and diagnostic kits for centralized laboratories and point-of-care testing.

Design, prototyping and supply of laboratory instruments and automation solutions integrated with immunoassay workflows, including gamma counters, automated washers, incubators and fully automated analyzers.

Expertise Areas

  • In vitro diagnostics (reagents and instruments)
  • Immunoassay development and optimization (RIA and ELISA)
  • Point-of-care lateral-flow diagnostics
  • Molecular diagnostics and nucleic-acid sample preparation
  • Show More (3)

Key Technologies

  • Radioimmunoassay (RIA)
  • Enzyme-linked immunosorbent assay (ELISA)
  • Lateral-flow immunoassays
  • Polymerase chain reaction (PCR)
  • Show More (5)

News & Updates

Site notice documents export permission and CE certification obtained for a COVID-19 antibody rapid diagnostic test (IgM/IgG).

Site notice documents export permission and CE certification obtained for an RT-PCR COVID-19 detection kit.

Site notice references news coverage about a rapid multi-drug detection device and related activities.

Company records acquisition of national GMP recognition for its manufacturing operations (Reg. No KCL-CBBA-14440).

Company lists certification to EN ISO 13485:2016 (notified body recorded).

Timeline documents product developments and national registrations for RIA/ELISA reagents, automated instruments and COVID-19 diagnostics (national registration numbers cited for several products).

View All News

Similar organizations

Browse all ORGANIZATIONS

JOIN OUR MAILING LIST

Stay Connected with MTEC

Keep up with active and upcoming solicitations, MTEC news and other valuable information.