Frequently Asked Questions

PRISES manufactures IVD and POCT rapid tests across six main categories: hCG pregnancy tests, LH ovulation tests, infectious disease rapid tests, respiratory disease rapid tests, drugs-of-abuse screening tests and urinalysis reagent strips. Products are supplied to distributors, importers, laboratories, medical institutions and private-label customers. Product availability differs by destination market, so please contact PRISES for the current catalog and market-specific product list.

PRISES supplies rapid tests in strip, cassette, midstream, digital and multi-panel cup formats. hCG pregnancy and LH ovulation tests are available in both consumer and professional formats. Infectious disease, respiratory and drug-screening products differ in format and sample type, and not every product is available in every format. The PRISES team can recommend a format based on your market, sales channel and end-user group.

Yes. For selected products PRISES can adjust the technical configuration, not only the branding. Examples include hCG sensitivity levels such as 10 mIU/mL or 25 mIU/mL, and multi-drug screening panels supplied as cups of up to 18 parameters or dip cards of up to 12 parameters with flexible parameter combinations. Combination and panel options for infectious disease and respiratory products are evaluated case by case. Any change to a technical configuration requires confirmation of the intended market, the regulatory route and the order quantity before it can be accepted.

Yes. PRISES provides OEM, ODM and private-label services for selected rapid test products. Customization can cover branding, product configuration, foil pouch, color box, label and instructions for use. Available options depend on the product, target market, order quantity and regulatory requirements. To start an evaluation, please provide your destination country, product list, estimated annual quantity and packaging requirements.

Customization can cover the brand name, logo, foil pouch, color box, product label, instructions for use, language version and selected kit configurations. The customer confirms artwork, dimensions and all printed text before production starts. All medical, performance, certification and regulatory statements printed on customized packaging are reviewed and approved by PRISES before printing, because incorrect claims on packaging can block customs clearance or product registration in the destination market.

PRISES operates under an ISO 13485 quality management system and holds a Class II medical device production licence in China. The facility has been subject to supplier and customer assessments. Selected products hold CE documentation or other product-specific certificates. Certification and registration status varies by product and by destination market, so customers should request and verify the documents for the exact product before registration, importation or commercial promotion.

Clinical performance for each PRISES product, including sensitivity and specificity, is stated in that product's instructions for use and supported by its performance evaluation data. Figures differ by product, sample type and cut-off level, so PRISES does not publish a single accuracy figure for the whole product range. Performance evaluation reports and validation summaries can be provided for a specific product on request, and are normally supplied as part of a registration or tender submission.

Shelf life is 24 or 36 months depending on the product. Storage conditions are 2-30°C or 4-30°C depending on the product, away from direct sunlight, with the device kept in its sealed foil pouch until use. The exact shelf life and storage range for each product are printed on the product label and stated in the instructions for use, and should always be verified against the documents for the specific product supplied.

PRISES can provide product specifications, instructions for use, packaging information, quality documents, certificate of analysis and batch documentation, and selected product-specific certification or registration materials. Batch records are traceable by lot number. Document availability varies by product, destination country and project stage, and some technical or confidential materials are provided only after product confirmation or under a confidentiality agreement.

Yes. PRISES supports customers registering products in their own market by providing the manufacturer documents normally required by health authorities, which may include the ISO 13485 certificate, free sale certificate, letter of authorization, product technical documentation and performance data. Notarization and legalization can be arranged where the destination authority requires it. The registration application itself is submitted by the local licence holder, since most markets require the applicant to be a locally established entity. Requirements differ significantly between markets, so please share the destination country and the product list at an early stage.

Quality complaints should be reported to PRISES with the product name, lot number, quantity affected, a description of the issue and supporting photos or test records. PRISES acknowledges the complaint, opens an investigation and tests the retained samples of the same lot at the factory. The customer receives an investigation outcome with the root cause assessment and the corrective action taken. Where a non-conformance is confirmed, replacement or another commercial remedy is agreed based on the order terms and the quantity affected.