Respiratory Diagnostics
Immunochromatographic and antigen combo tests covering influenza A/B, SARS-CoV-2, RSV, ADV, and Human Metapneumovirus from nasal specimens.
Innovation, Never Stop
POCT Rapid Test Kits and IVD Consumables for Global Distributors
ISO 13485-certified manufacturer supplying rapid diagnostic kits and OEM IVD solutions to distributors and partners across the US, EU, SEA, and China.
20+ years
Manufacturing experience
China, United States, Germany, Thailand
Export markets
ISO 9001, ISO 13485, NMPA Class III Medical Device Certificate
Certifications
FDA GMP-standard workshop
Regulatory compliance
ChinaUnited StatesGermanyThailand
ISO 9001ISO 13485NMPA Class III Medical Device CertificateNational High-Tech Enterprise
Supplier-declared, pending confirmation
Diagnostic Product Categories
Antimicrobial Resistance Rapid Tests
Qualitative ICA-based tests detecting carbapenemases, beta-lactamases, and MCR-1 enzyme directly from bacterial colonies, with results in 15 to 30 minutes.
Gastrointestinal and Infectious Disease Diagnostics
Rapid tests for gastrointestinal pathogens, tuberculosis, and pulmonary biomarkers using ICA and fluorescence immunoassay platforms.
Fluorescence Immunoassay (FIA) Kits
Quantitative FIA kits designed for use on fluorescence readers, providing higher sensitivity for biomarker detection at the point of care.
Sampling Swabs and Transport Media
Flocked and standard swabs with matched viral and universal transport media for reliable specimen collection and preservation.
OEM IVD Solutions
End-to-end OEM manufacturing from raw material sourcing and assay development through regulatory filing support, white-label packaging, and export documentation.
Why Source From Entrong Medical
NMPA Class III and ISO 13485
Entrong Medical holds NMPA Class III Medical Device certification alongside ISO 13485 quality management accreditation, satisfying the documentation requirements of most import regulators in the US, EU, and SEA markets.
FDA GMP-Standard Manufacturing
The production workshop is designed and operated to US FDA GMP requirements, reducing the compliance burden for distributors entering or already active in the North American market.
Three Diagnostic Platforms
Manufacturing spans immunochromatographic (ICA), fluorescence immunoassay (FIA), and molecular diagnostic platforms, allowing distributors to source complementary product lines from a single supplier.
Full-Scope OEM Capability
Entrong Medical supports OEM partners from raw material procurement and assay development through white-label packaging and export documentation, covering the entire product lifecycle under one roof.
Antimicrobial Resistance Test Portfolio
The EZER AMR range includes CTX-M beta-lactamase groups 1, 2, 8, 9, and 25, OXA-23 carbapenemase, and MCR-1 enzyme detection, addressing a diagnostics segment with growing regulatory and clinical demand globally.