Qualified diagnostic enquiries

NEWSCEN Treponema Pallidum Antibody Rapid Test

Treponema Pallidum antibody rapid-test supply for qualified distribution projects, subject to current destination-market status and documentation review.

Regulatory transparency: WODE is the manufacturer of the NEWSCEN TP programme. The supplied 2022 registration notice is treated as historical supporting documentation; current product eligibility, representative details and destination-market requirements are verified before quotation.
Treponema Pallidum antibody rapid-test product and documentation concept
TP antibody rapid test

Commercial routes

Choose the supply model that fits your operation

The provided registration notice is a historical 2022 document under Directive 98/79/EC. It is not used as a blanket statement of current EU market eligibility; the applicable route must be confirmed for each destination before supply.

Qualified distributor route

Importer, destination country and intended channel are reviewed before commercial discussion.

Document-first review

The supplied registration notice and available technical documents are checked against current market requirements.

Pack localisation

Label language, instructions and pack configuration are discussed only after regulatory responsibilities are clear.

Tender or programme supply

Forecast, delivery plan and requested evidence are reviewed as part of the qualification process.

Product matrix

Current project references

Final specification is confirmed by quotation

Specification areaCurrent project reference
ProductTreponema Pallidum (TP) Antibody Rapid Test
Provided documentNotification of Registration, certificate R20201211-17; registration RPS/560/2022
Document date8 March 2022
Referenced frameworkEuropean Council Directive 98/79/EC
Current-market cautionPresent eligibility and transition requirements must be confirmed for the destination before quotation

Development options

Build the product around the market brief

01Destination-market document review
02Label and IFU language planning
03Commercial pack discussion
04Forecast and supply coordination
RFQ checklist

What to send for a useful quotation

A clear brief lets the team confirm feasibility, sample path, packaging, documentation and a commercial quantity without exposing internal cost data.

  • Destination country and importer details
  • Intended user and channel
  • Required registration/tender documents
  • Pack and language requirements
  • Quantity and forecast

Ready to build your brand?

Send the target market, product direction and packaging idea.

Start an OEM project

Need bulk or semi-finished supply?

Tell us how your filling operation works and what you need to source.

Discuss supply