+86-18343147735
IVD Rapid Test Kit Manufacturer · Since 2015
A Rapid Test Kit Manufacturer Built for Distributors Who Need Verifiable Compliance
Conlight Medical designs and manufactures rapid diagnostic test kits — from drug and infectious-disease screening to water, food and heavy-metal residue testing — inside a GMP-certified facility with ISO 13485 & MDSAP (BSI) quality systems, FDA 510(k) clearance and 50+ EU CE certified products. 8 production lines, 15M+ units/year capacity, full OEM/ODM support.
ISO 13485 Certified MDSAP Certified (BSI) FDA 510(k) Cleared — K232228 160+ EU CE Certificates
15M+
Units / year manufacturing capacity across 8 GMP production lines
10+
Years in IVD Manufacturing
300+
Team Members
8
GMP Production Lines
15M+
Units / Year Capacity
50+
EU CE Certified Kits
100+
Patents & IP Filings
Products & Solutions
One-Stop Rapid Test Kit Manufacturing, by Application
Every category below is manufactured in-house on Conlight's own GMP lines and available for standard catalog ordering or OEM/ODM private-label programs.
Drug & Infectious Disease Rapid Tests
FDA 510(k) cleared 12-panel drug of abuse test kits and cups (K232228), configurable for 2–14 substances and up to 6 adulterants, plus infectious-disease antigen/antibody rapid tests and 14-parameter urinalysis reagent strips.
Explore Drug & Infectious Disease Tests →
Heavy Metal Test Kits
Rapid colloidal-gold test kits for lead, arsenic and mercury contamination in water, soil, paint, toys, ceramics and consumer goods — built for compliance screening and consumer safety programs.
Explore Heavy Metal Test Kits →
Water Quality Test Kits
Drinking water, swimming pool, spa and aquarium test strips and meters covering free/combined/total chlorine, chloramines, bacteria (E. coli) and glyphosate residue — plus 4-in-1, 7-in-1 and 10-in-1 digital TDS meters.
Explore Water Test Kits →
Food & Agricultural Residue Tests
Colloidal gold immunoassay test kits for herbicide and veterinary drug residues — including Glyphosate, Melamine, Ractopamine, Salbutamol, Ceftiofur, Tilmicosin, Oxacillin and β-lactamase — for feed, meat and dairy safety screening.
Explore Food Safety Tests →
A1/A2 Milk & Dairy Test Kits
Rapid colloidal-gold test cards for A2-β-casein identification in milk, supporting dairy processors and A2-milk brand verification programs — plus pet allergy and wellness rapid test panels.
Explore A1/A2 & Pet Testing →
Custom OEM/ODM Development
Bring your own brand, panel configuration or target-market regulatory requirement — Conlight's R&D and registration teams support custom formulation, packaging, inserts and CE/FDA/local registration.
Start an OEM/ODM Inquiry →
Why Conlight
Why Global Distributors Choose Conlight as Their Manufacturing Partner
GMP
GMP-Certified Manufacturing Scale
8 dedicated IVD production lines with a designed capacity of 15M+ units/year, supporting both trial orders and recurring bulk OEM/ODM programs.
✓
Verifiable Regulatory Compliance
ISO 13485 and MDSAP certified by BSI; FDA 510(k) cleared 12-panel drug test (K232228); 160+ products with EU CE certificates.
OEM
Full OEM/ODM & Private Label
Custom panel configuration from 2–14 analytes, private-label packaging and inserts, and registration support for your target market.
R&D
In-House R&D & Patented Technology
100+ patents and IP filings, including China's first PCT international patent for a health test kit — giving distributors early access to new panels.
🌐
Global Distribution Experience
Products shipped and supported across North America, Europe, Latin America, Africa and Australia, with local after-sales assistance.
300+
300+ Team, Fast Response
A 300-person team spanning R&D, QC, regulatory affairs and after-sales, built to move quickly on custom requests and technical questions.
Certifications & Compliance
Certifications & Regulatory Compliance
Rapid test kits sit close to health and safety decisions, so we keep our compliance claims specific and checkable rather than generic.
ISO 13485The international quality management system standard specific to medical device design, production and servicing. Conlight's manufacturing system is certified to this standard.
MDSAP (Medical Device Single Audit Program)A single regulatory audit, recognized across multiple markets (including the US, Canada, Brazil, Japan and Australia), issued to Conlight by the British Standards Institution (BSI).
FDA 510(k) ClearanceUS FDA market clearance confirming a device is substantially equivalent to a legally marketed predicate. Conlight's 12-panel drug test kit and test cup hold FDA 510(k) clearance, K number K232228.
CE MarkingConfirms a product meets EU health, safety and environmental protection requirements. As of December 2023, 160 of Conlight's IVD products held EU CE certificates.
Full-resolution certificates and registration documents are available in our Downloads center or on request — ask your sales contact to send the PDF set relevant to your target market.
Applications
Where Our Rapid Test Kits Are Used
Hospitals & Clinics
Point-of-care infectious disease and urinalysis screening for clinical and laboratory settings.
Workplace & Occupational Health
Pre-employment and random drug screening programs for employers and occupational health providers.
Environmental & Water Utilities
Drinking water, swimming pool and spa water quality monitoring for municipal and commercial operators.
Food, Agriculture & Veterinary
Herbicide and veterinary drug residue screening for feed mills, farms, processors and food safety labs.
Dairy & Consumer Goods
A1/A2 milk verification for dairy processors, and heavy-metal screening for toys, ceramics and consumer products.
Import, Export & Distribution
Private-label and OEM programs for distributors bringing certified rapid test kits into new regional markets.
How We Work
From Inquiry to Delivery — Our OEM/ODM Process
Inquiry & Technical Consultation
Share your target analytes, panel format and destination market; our team scopes feasibility and timeline.
Formulation & Sampling
R&D configures the panel (2–14 analytes) and produces samples for your validation.
Regulatory & Registration Support
Guidance on CE, FDA and local registration requirements for your target country.
GMP Mass Production
Manufacturing across our 8 certified production lines with in-process quality control.
Final QC & Certification
Batch release testing, documentation and certificate packaging for customs and distributors.
Logistics & After-Sales
Global shipment coordination plus local after-sales support for technical questions.
FAQ
Frequently Asked Questions
What is a rapid test kit and how does it work?
A rapid test kit is an in-vitro diagnostic (IVD) device that detects a specific substance — a drug metabolite, pathogen antigen, heavy metal or chemical residue — in a sample such as urine, blood, water or food, typically using colloidal gold immunoassay (lateral flow) technology. Results appear as visible test lines within 5–15 minutes, with no lab equipment required.
Is Conlight a licensed rapid test kit manufacturer?
Yes. Conlight operates a GMP-certified facility with 8 IVD production lines, holds ISO 13485 and MDSAP certification from BSI, and its 12-panel drug test kit and cup are FDA 510(k) cleared under K232228. Over 50 of its test kits carry EU CE certification.
Can you provide OEM/ODM or private-label rapid test kits?
Yes. We support custom panel configuration, private-label packaging and inserts, and registration guidance for your target market. See our OEM/ODM process above or contact us to start a scoping conversation.
What certifications does Conlight hold?
ISO 13485 and MDSAP certification from BSI; FDA 510(k) clearance (K232228) for the 12-panel drug test kit and cup; and, as of December 2023, EU CE certificates on 160 IVD products, with 12 products holding China NMPA registration.
What is the minimum order quantity (MOQ) for custom rapid test kits?
MOQ depends on the panel, packaging format and certification required. With 15M+ units/year of combined production capacity, we can typically accommodate both smaller trial orders for new distributors and large recurring OEM/ODM volumes — share your target panel and country for an exact quote.
How long does sampling and mass production take?
Standard catalog items usually ship samples within a few business days. Custom OEM/ODM formulations follow the consultation → formulation/sampling → regulatory support → GMP production sequence outlined above; exact lead time depends on panel complexity and any target-market registration needed.
Get In Touch
Get Your Rapid Test Kit Quote
Tell us your target panel, market and volume — our team replies within 24 hours with pricing, MOQ and lead time.
Talk to Conlight Medical
For catalog requests, OEM/ODM scoping or regulatory questions, reach us directly:
Address No. Room 201, NanYu XinCun, ZhuJing Town, JinShan District, Shanghai, China
Phone +86 183 4314 7735
Email admin@hkconlight.com
WhatsApp +86 181 1631 0929