Qualified diagnostic enquiries

NEWSCEN Distributor Document Review

WODE is the manufacturer and NEWSCEN is a WODE-produced rapid-test product line. Qualified distributors can request a product-, version- and destination-specific document review before quotation, registration planning or commercial supply discussion.

Request a project review Quality and regulatory documents

Regulatory status and document applicability are not transferred from one product, version or market to another. Current files are reviewed against the exact catalogue item and destination.

Reviewed 22 July 2026WODE Product & Export TeamB2B procurement resource

NEWSCEN HIV and Treponema Pallidum rapid-test packaging presented for qualified distributor document review — NEWSCEN distributor review

Commercial routes

Choose the route before quotation

OEM / ODM / BULK / PRIVATE LABEL

The best route depends on the approved product, buyer capability, packaging, destination, commercial quantity and requested documentation.

Product identification

Confirm HIV (1+2) antibody or Treponema Pallidum antibody rapid test, catalogue reference, format and requested version.

Buyer qualification

Identify the importing entity, distributor role, target channel and relevant regulatory or tender experience.

Market document review

Map the requested certificate, declaration, IFU, label, technical or quality document to the destination requirement.

Commercial route

Proceed to sample, document package, registration support discussion and quotation only after the basic market route is understood.

Decision matrix

Facts procurement teams should confirm

No unsupported fixed assumption

Decision area	Current WODE guidance and confirmation point
Manufacturer relationship	WODE Biotechnology Co., Ltd. is the manufacturer; NEWSCEN is a product line manufactured by WODE.
Product scope	NEWSCEN HIV (1+2) Antibody Rapid Test and NEWSCEN Treponema Pallidum Antibody Rapid Test.
Buyer information	Legal company name, website, importer or distributor role, contact person and relevant market experience.
Market information	Destination country, intended professional channel, local classification, registration route and authority or tender requirement.
Document request	Exact file name, purpose, required language, issue-date condition and whether a notarised or legalised copy is requested.
Commercial information	Estimated quantity, sample need, target timing, pack language and delivery destination.

Release gates

Checks before commitment

Match the exact productDo not use an HIV document for TP or a document from another configuration without written applicability confirmation.

Check version controlConfirm document number, revision, issue date, product reference and current status before submission.

Review the destinationAssess local registration, importer, label, language, professional-use and post-market responsibilities.

Control public claimsWebsite wording does not replace the current IFU, certificate, declaration or authority decision.

Protect technical recordsConfidential or controlled files are supplied through the qualified review route and only for the stated purpose.

Buyer questions

Answers that prevent RFQ delays

Does NEWSCEN manufacture the tests?

WODE is the manufacturer. NEWSCEN is the WODE-produced product line used for the identified rapid tests.

Does one EU-related document cover every market?

No. Product version, current document status, local registration, language, importer and destination requirements must be reviewed.

Can a distributor request documents before ordering?

Yes. Provide the legal entity, target country, exact product and purpose so WODE can define the appropriate review level.

Are the rapid tests sold as consumer retail products through this website?

No. The website routes qualified B2B and professional distribution enquiries rather than consumer checkout.

Related resources

Continue the procurement review

All buyer resources ->

RFQ checklist

Send the facts needed for a useful quotation

WODE reviews feasibility, sample path, packaging, quality gates and commercial quantity from the information below. Internal formula and cost data remain confidential.

Open the RFQ form Email the brief

Legal company and distributor role
Exact NEWSCEN product
Destination and intended channel
Requested document and purpose
Pack language and quantity
Registration, tender or timing requirement

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