Medical & Regulatory Disclaimer

Professional use only

All in-vitro diagnostic (IVD) test reagents and point-of-care testing (POCT) devices described on this website are intended for purchase and use by professional healthcare institutions and qualified distributors, or for registration and distribution in accordance with the medical-device regulations of each importing country. These products are not intended for personal self-diagnosis of disease.

Not a diagnostic conclusion

A reactive (positive) result from any rapid test described here is a screening (presumptive) result, not a definitive diagnosis. Confirmatory testing by an appropriate reference method — performed and interpreted by qualified professionals — is required before any clinical or legal decision.

Regulatory scope

Regulatory status (CE marking, FDA, NMPA, ISO 13485) varies by product and by market, and is stated on a per-product basis. The presence of a marking on one product line does not imply the same status across all products. Verify the specific product's regulatory status before ordering for a regulated market.

No medical advice

The content on this website is provided for business-to-business informational purposes only and does not constitute medical advice, a diagnosis, or a treatment recommendation. Consult a qualified healthcare professional for any medical question.

Information accuracy

Product specifications, cut-offs and regulatory information are provided for reference and may change. Final specifications are confirmed in the product datasheet, instructions for use (IFU) and commercial agreement.