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Golden Time IVD Division

Lateral Flow IVD Rapid Tests
for Global Distributors

ISO 13485 & CE certified manufacturer. Colloidal gold rapid tests for 100+ countries.

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✓ ISO 13485 Certified ✓ CE Marked (IVDD / IVDR) ✓ ISO Class 8 Cleanroom ✓ 4 Product Categories ✓ 100+ Countries

Browse Our Product Categories

4 specialized categories · Complete IVD rapid diagnostic coverage

Infectious Disease

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

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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 Tests

HCG pregnancy, LH ovulation, FSH menopause tests

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Product Catalog

50+ rapid diagnostic tests · 4 categories · Full specifications and order codes.

PDF Catalog

Updated 2026 · 8.5 MB

Golden Time IVD Diagnostics Catalog

Lateral flow rapid tests for infectious disease, respiratory, drug of abuse, and fertility. ISO 13485 · CE Marked · OEM/private label ready.

  • ✓ 50+ tests · 4 categories
  • ✓ Specs, sample types, order codes
  • ✓ OEM/private label ready
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For custom product specifications or private label catalogs, please contact our team.

Designed for Your Workflow

Solutions tailored to different healthcare settings and business models

Hospitals & Clinical Labs

High-volume rapid screening for infectious disease departments, emergency rooms, and diagnostic laboratories.

Pharmacy & Retailer

Consumer-facing pregnancy, ovulation, and wellness rapid tests for pharmacy chains and retail distributors — retail-ready packaging with multilingual instructions.

Workplace & Government

Drug of abuse panels for pre-employment screening, workplace safety, occupational health, and government screening programs.

OEM Partners & Distributors

Private label solutions with custom branding, packaging design, and flexible MOQ for regional distribution.

Frequently Asked Questions

What IVD rapid test categories do you manufacture?
Golden Time manufactures lateral flow immunoassay (LFIA) rapid tests across four categories: infectious disease (HIV, Hepatitis B/C, Syphilis, Malaria, Dengue, Tuberculosis, H. pylori), respiratory disease (Influenza A/B, COVID-19, RSV), drug of abuse (multi-panel dip cards, cups, urine and saliva), and fertility tests (HCG pregnancy, LH ovulation, FSH menopause).
Are your IVD rapid tests ISO 13485 and CE marked?
Yes. Golden Time IVD rapid tests are manufactured under ISO 13485:2016 quality management system and carry CE marking under EU IVD Directive (IVDD) and IVD Regulation (IVDR). Our ISO Class 8 (100,000-grade) cleanroom ensures consistent production quality for global distribution.
Can you configure custom test panels or private label rapid tests?
Yes. We support custom panel configuration for drug of abuse tests (select specific drug markers and cut-off levels), and offer full private label services including custom branding, packaging design, and multilingual insert documents. OEM minimum order quantities are flexible for regional distributors.
What sample types do your rapid tests support?
Our rapid tests support whole blood, serum, plasma, urine, nasal swab, and saliva sample types depending on the specific test. Cassette, strip, and mid-stream formats are available. Contact us for format specifications by product category.

Need a Custom Panel or Private Label?

Custom panels · Private labeling · Documentation support. Quote within 12 hours.

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