Qualified diagnostic enquiries

NEWSCEN HIV (1+2) Antibody Rapid Test

A professional-use HIV (1+2) antibody rapid-test programme for qualified distributors, with destination-market and document review before quotation.

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Regulatory transparency: WODE is the manufacturer of the NEWSCEN HIV (1+2) programme. Certificate scope, holder details, product applicability and destination-market status are verified against the current project records before quotation.

NEWSCEN rapid-test product and documentation concept for qualified distribution — HIV (1+2) rapid test

Commercial routes

Choose the supply model that fits your operation

Diagnostic supply is not quoted as a generic consumer product. Intended user, destination market, importer role, registration pathway, label language and requested documentation must be reviewed first.

Professional-use enquiry

The current product summary identifies professional laboratory use.

Sample types

Serum, plasma and whole-blood formats are listed in the supplied product summary.

Document review

Available certificates and product documents are reviewed against the destination market.

Distributor qualification

Importer details, market scope, forecast and regulatory responsibilities are confirmed before quotation.

Product matrix

Current project references

Final specification is confirmed by quotation

Specification area	Current project reference
Product	NEWSCEN HIV (1+2) Antibody Rapid Test
Method/reference	Rapid antibody test; colloidal-gold format stated in the supplied product summary
IVDR QMS certificate	V13 095791 0013 Rev. 00; TÜV SÜD notified body 0123; valid 8 Aug 2025 to 7 Aug 2030
Certificate scope	EU 2017/746 Annex IX Chapter I quality-management-system certificate; Class D device group
Important distinction	The QMS certificate is not presented as a standalone product certificate; product-specific evidence is reviewed separately