FDA-Cleared 12-Panel At-Home Drug Test Kit Empowers Families and Workplaces with Rapid Screening

Conlight Diagnostics launches an FDA 510(k)-cleared immunoassay Urine cup test, enabling self-administered screening for 12 common drugs of abuse in under 10 minutes.

Shanghai, China – June 2025

Conlight Diagnostics, a Shanghai-based medical device innovator, has announced the international launch of its FDA-cleared At-Home Multi-Drug Urine Test Cup, targeting both consumer and professional markets. The product features a 12-panel immunochromatographic assay, offering fast and accurate results for common drugs including AMP, MET, MOP, BZO, KET, MDMA, OXY, and others.

A Safer and Smarter Way to Screen

Designed for ease of use, the integrated cup enables users to collect, test, and interpret results in one step. With a detection window ranging from 3 to 8 minutes, this point-of-care solution minimizes contamination risks and simplifies interpretation through colorimetric strips.

“Our mission is to make clinical-grade screening accessible to households, schools, clinics, and employers,” says Jackie Ho, Chief Strategist at Conlight. “This kit is not only about detection—it’s about trust, prevention, and timely action.”

Key Use Cases

- Youth behavioral monitoring & parenting support

- Employee pre-employment drug screening

- Substance abuse recovery tracking

- Public health outreach & telemedicine screening kits

Technology & Certification

• Methodology: Immunochromatographic lateral flow
• Certification: FDA 510(k) Cleared (Class II), ISO13485
• Formats: 4 / 6 / 12 / 14 drug panels (customizable)
• Shelf Life: 24 months at room temperature

Distribution & OEM Opportunities

Conlight offers OEM and white-label services for international distributors. With its manufacturing base and regulatory readiness, the company is actively seeking global partnerships across eCommerce, pharmacy, telehealth, and rehabilitation networks.

📩 Contact for partnership inquiries: info@conlight.com

▲ Image: Conlight’s FDA-cleared 12-panel urine drug test kit (at-home version)