Lateral Flow IVD Rapid Test Manufacturer for Global Distributors

ISO 13485 & CE certified manufacturer of colloidal gold immunochromatographic rapid tests. Supplying distributors, hospitals, private clinics, and government health programs worldwide.

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More Than a Manufacturer — Your Complete IVD Solution Partner

From product development and CE certification support to bulk production and international shipping, we handle every step of bringing IVD products to your market. One partner, every stage.

Our Technology — Lateral Flow Immunoassay (LFIA)

All Golden Time rapid test kits utilize lateral flow immunoassay (LFIA) technology, also known as colloidal gold immunochromatographic assay. This one-step rapid test methodology delivers reliable qualitative results in as little as 10-15 minutes without requiring specialized laboratory equipment.

Our colloidal gold rapid tests are ideal for point-of-care testing (POCT) in hospitals, clinics, pharmacies, and field settings. The immunochromatographic strip format ensures consistent performance across diverse environments, making our lateral flow tests the preferred choice for distributors serving healthcare facilities in Southeast Asia, Africa, Middle East, Europe, and Latin America.

15 min

Reading time

No Equipment

Required for testing

POCT Ready

Point-of-care suitable

Our IVD Product Categories

Comprehensive range of lateral flow rapid diagnostic tests for diverse clinical applications

Infectious Disease

HIV, Hepatitis B/C, Syphilis, Malaria, Dengue, Tuberculosis, H. pylori and more

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Respiratory Disease

Influenza A/B, COVID-19, RSV antigen rapid tests

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Drug of Abuse

Multi-panel dip cards and cups, single drug tests, urine and saliva

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Fertility Test

HCG pregnancy, LH ovulation, FSH menopause, SP10 sperm tests

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Why Choose Our IVD Products

Trusted by distributors and healthcare facilities across 50+ countries

ISO 13485 Certified Manufacturing

Quality management system certified for medical device manufacturing

CE-IVDR Compliant Products

Products meet European In Vitro Diagnostic Regulation requirements

Immunochromatographic Test Strip Expertise

10+ years experience in colloidal gold lateral flow technology

Custom OEM/ODM Services

Private label branding, custom packaging, and product development

Multiple Sample Types

Whole Blood, Serum, Plasma, Urine, Saliva, and Stool test capabilities

Bulk Supply with Competitive MOQ

Flexible minimum order quantities for distributors worldwide

Who We Serve

B2B partnerships with healthcare organizations worldwide

Distributors

Hospitals

Private Clinics

Diagnostic Labs

Government Agencies

NGOs

Pharmacies

OEM/ODM Manufacturing Capabilities

Partner with us for custom IVD OEM/ODM solutions. As a private label rapid test manufacturer, our lateral flow expertise and flexible manufacturing enable tailored products for your market requirements.

Custom branding and packaging design
Private label solutions for distributors
Custom panel configurations (drug of abuse)
Regulatory documentation for market registration
Flexible MOQ based on product type

Certifications

ISO 13485 CE Marked GMP

Target Markets

Southeast Asia • Africa • Middle East • Europe • Latin America

Frequently Asked Questions

What rapid test categories do you manufacture?

We manufacture IVD rapid tests across 4 categories: Infectious Disease (HIV, Hepatitis, Malaria, Dengue), Respiratory Disease (Flu, COVID-19, RSV), Drug of Abuse (multi-panel urine and saliva tests), and Fertility (pregnancy, ovulation, menopause). All use lateral flow immunoassay technology.

What is lateral flow immunoassay technology?

Lateral flow immunoassay (LFIA) uses colloidal gold conjugates on immunochromatographic test strips for rapid qualitative detection. Results appear in 10-15 minutes without laboratory equipment, making it ideal for point-of-care testing in clinics, pharmacies, and field settings.

Are your IVD products CE marked?

Yes, our IVD rapid tests are CE marked under the In Vitro Diagnostic Regulation (IVDR), enabling legal sale throughout the European Economic Area. We also support registration in other markets including GCC, ASEAN, and African countries.

Can you produce custom-branded rapid tests?

Yes, private label OEM is our specialty. We offer custom branding, packaging design, multi-language instructions, and custom panel configurations for drug tests. Contact us to discuss your branding requirements.

What sample types do your tests support?

Our tests support multiple sample types including whole blood, serum, plasma, urine, oral fluid (saliva), nasopharyngeal swab, nasal swab, and stool. Specific sample types vary by product and are indicated in each product documentation.

Looking for a Reliable Lateral Flow IVD Manufacturing Partner?

Get our complete product catalog and OEM pricing. Our sales team responds within 12 hours.

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