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1. Drugs of abuse Test 2. Respiratory disease Test 3. Infectious Disease Test 4. Women's Health Test 5. Cardiac Marker Test 6. Tumor Marker Test 7. Inflammatory Marker Test 8. Veterinary Test
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Comprehensive IVD Product

Browse Rapid Test Kits by Diagnostic Category

As an internationally certified manufacturer, we engineer Point-of-Care Testing (POCT) solutions that deliver clinical-grade accuracy. Our rapid diagnostic portfolios ensure lot-to-lot consistency, low CVs, and strict global regulatory compliance for global distributors and healthcare providers.

Comprehensive IVD Product Portfolio

Leveraging our mature colloidal gold and fluorescence immunoassay platforms, we provide deep-vertical screening solutions tailored for diverse clinical demands.

Drugs of Abuse Test Kits
Category 01

Drugs of Abuse Test Kits

Our DOA test kits screen for over 40 different illicit substances, including cocaine, THC, fentanyl, and synthetic cannabinoids. The product range encompasses a variety of formats—such as single-panel strips, multi-panel cassettes, integrated collection cups, and dip cards—tailored for the analysis of urine, oral fluid, and hair samples. All products bear the CE marking, signifying full compliance with IVDR regulatory requirements; the Minimum Order Quantity (MOQ) for standard configurations is 5,000 units.

Explore DOA Solutions →
Respiratory Disease Test Kits
Category 02

Respiratory Disease Test Kits

Equip emergency departments and clinics with high-sensitivity multiplex screening. Our respiratory panels accurately differentiate Influenza A/B, RSV, and COVID-19 from single nasopharyngeal or nasal swab samples, enabling rapid triage and precise antiviral administration.

View Respiratory Panels →
Infectious Disease Test Kits
Category 03

Infectious Disease Test Kits

Designed for whole blood, serum, and plasma, these robust assays detect blood-borne pathogens (HIV, HBV, HCV, Syphilis) and tropical diseases (Malaria, Dengue) with exceptional diagnostic specificity. Heat-stable formulations ensure performance in demanding geographic climates.

Discover Infectious Tests →
Women's Health Test Kits
Category 04

Women's Health Test Kits

Delivering ultra-early detection sensitivity (e.g., 10-20 mIU/mL for hCG), our pregnancy and LH ovulation monitoring kits are optimized for both professional gynecological use and OTC pharmacy retail. Full private-label packaging available for distributors.

See Women's Health Range →
Cardiac Marker Test Kits
Category 05

Cardiac Marker Test Kits

Empowering chest pain centers with quantitative fluorescence immunoassays. Our cTnI, NT-proBNP, CK-MB, and D-Dimer test panels provide highly accurate concentration readouts within 15 minutes, crucial for acute myocardial infarction (AMI) intervention.

Explore Cardiac Markers →
Tumor Marker Test Kits
Category 06

Tumor Marker Test Kits

Facilitating accessible early-stage risk stratification, these rapid screening assays detect key oncology markers including AFP, CEA, PSA, and FOB. Low sample volume requirements make them ideal for large-scale population health screening programs.

View Tumor Markers →
Inflammatory Marker Test Kits
Category 07

Inflammatory Marker Test Kits

Vital for antibiotic stewardship and sepsis management. Our rapid CRP, PCT, and SAA assays allow physicians to quickly perform differential diagnosis between bacterial and viral infections directly at the patient's bedside.

Discover Inflammatory Tests →
Veterinary Test Kits
Category 08

Veterinary Test Kits

Species-specific, cold-chain-free rapid diagnostic solutions for companion animals (feline/canine Parvovirus, Distemper) and livestock pathogen surveillance. Engineered for high reliability in field and clinic environments.

Explore Veterinary Kits →

Standardized GMP Manufacturing Protocol

Quality is engineered into every step. Discover how our rigorous 6-stage production sequence ensures that every rapid test kit performs with zero compromise on analytical sensitivity and specificity.

01

Membrane Sticking

Precision lamination of high-grade nitrocellulose (NC) membranes onto adhesive backing cards. This automated process ensures uniform capillary flow rates and establishes distinct, reliable test lines.

02

C/T Solution Preparation

Formulation of highly purified colloidal gold or fluorescent-labeled conjugates. Specific antibodies for Control (C) and Test (T) lines are precisely dispensed and validated against strict optical density benchmarks.

03

Drying & Curing

All treated components are cured in advanced humidity-controlled drying rooms (RH ≤ 20%). This locks in the biological activity of the proteins, guaranteeing a stable 24-month shelf life.

04

Assembling & Cutting

Automated integration of conjugate, sample, and absorbent pads. Programmed slitters then cut the assembled master cards into uniform individual strips (e.g., 3.0mm, 4.0mm) with exact millimeter precision.

05

Primary Packaging

Individual strips or cassettes are hermetically sealed into medical-grade aluminum foil pouches via robotic assembly lines, including highly absorbent desiccants to prevent any moisture degradation.

06

Secondary Packaging

Completed pouches undergo final random lot sampling for cross-reactivity testing before automated boxing, batch coding, and labeling—ensuring full traceability compliant with CE IVDR and FDA guidelines.

Diagnostics Across Every Clinical Setting

Our rapid test kits are deployed across diverse healthcare ecosystems — from urban hospital emergency departments to remote community health posts.

Toxicology & Workplace
🧪

Toxicology & Workplace

Pre-employment and random screening programs at industrial sites and correctional facilities rely on our DOA panels for defensible results.

Emergency & Urgent Care
🏥

Emergency & Urgent Care

ED triage teams use our respiratory panels to distinguish Flu A/B from COVID-19, enabling rapid isolation protocols within minutes.

Global Health Programs
🌍

Global Health Programs

WHO-aligned NGOs deploy our infectious disease tests in low-resource settings for HIV, malaria, and syphilis screening without a cold chain.

Reproductive Clinics
🔬

Reproductive Clinics

OB/GYN practices and OTC channels offer our women's health tests for pregnancy confirmation, ovulation prediction, and menopausal status.

Cardiology & Critical Care
❤️

Cardiology & Critical Care

Our cardiac marker cassettes are standard equipment in chest-pain units, where rapid troponin results guide life-critical treatment pathways.

Oncology Screening
🎗

Oncology Screening

Population-level cancer screening initiatives use our tumor marker rapid tests as cost-effective first-pass tools for early risk identification.

Antibiotic Stewardship
⚡

Antibiotic Stewardship

Hospitals use our CRP and PCT rapid tests as decision-support tools, reducing empiric antibiotic prescribing by distinguishing bacterial from viral infections.

Veterinary Management
🐾

Veterinary Management

From companion animal practices to farm biosecurity programs, our veterinary tests enable rapid on-site pathogen detection.

Internationally Recognized Certifications

Our quality management systems are independently audited and certified to the most stringent international regulatory standards.

ISO 13485 Certificate

Medical Device QMS

ISO 9001 Certificate

Quality Management

MDSAP Certificate

Multi-Country Audit

Brazil ANVISA BGMP

Brazilian Market Access
Custom Solutions

OEM & ODM Drug Test Manufacturing — Built for Your Market

We provide end-to-end OEM and ODM services for distributors, healthcare brands, and government procurement bodies seeking fully white-labeled drug screening solutions compliant with local regulatory frameworks.

  • Fully Configurable Drug Panels Choose from 40+ validated drug antibodies. Mix any combination of urine, saliva, or hair parameters into a single panel — including emerging analytes like fentanyl, buprenorphine, and synthetic cannabinoids.
  • Private Labeling & Custom Packaging Full artwork design service, multi-language IFU inserts, and custom carton/pouch specifications. MOQ from 5,000 units.
  • Adjustable Cut-off Levels on Request For jurisdictions requiring non-standard screening thresholds (e.g., DOT, DFWP, EMCDDA), we can reformulate cut-offs to meet your regulatory requirements.
  • Regulatory Filing Support Comprehensive technical documentation for CE marking, FDA 510(k), TGA, ANVISA, and NMPA registration — reducing your time-to-market by up to 6 months.
60+
Countries Served
200M+
Tests Manufactured Annually
15+
Years in IVD Manufacturing

Frequently Asked Questions

Standard product lead times are 15–25 business days for stock items and 30–45 business days for custom-labeled orders. We maintain strategic buffer stock of high-volume SKUs for urgent public health requirements.

Absolutely. Sample kits (typically 5–25 units per product line) are available for qualified distributors and laboratory evaluators. Samples are shipped at cost with full technical documentation including IFU and safety data sheets.

Our products carry CE IVD marking for European market access, and are manufactured under an ISO 13485-certified QMS audited through the MDSAP program. Many products also carry Brazil ANVISA registration.

Most of our rapid test kits are formulated for ambient storage at 2–30°C (36–86°F) with a shelf life of 18–24 months, making them well-suited to supply chains and markets without continuous cold-chain infrastructure.

Request a Wholesale Quote

Tell us your target market, required testing parameters, and estimated annual volume. Our global sales team will respond within 24 hours.

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