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PAXgene Blood DNA Tube

by Preanalytix GmbH

510(k) K142821

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142821↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 7 Oct 2026. What this means

Regulatory status

as of registry sync 7 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK142821 Date9 Sep 2015ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 7 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
PJE
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PAXgene Blood DNA Tube is a blood/plasma collection device designed for DNA testing. It stabilizes and preserves blood samples to ensure high-quality nucleic acid extraction for downstream molecular analysis, including genomic and epigenetic studies.

This single-use device is intended for in vitro diagnostic use in clinical chemistry settings. Supplied sterile and pre-labeled, it requires no additional preparation beyond standard blood collection procedures. Authorized under FDA 510(k) clearance and IVDR compliance, it adheres to strict regulatory standards for diagnostic devices, ensuring reliability and traceability in laboratory workflows.

Other devices from Preanalytix GmbH

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of molecular analyses can the PAXgene Blood DNA Tube support for blood samples?

    The PAXgene Blood DNA Tube is specifically designed to stabilize and preserve blood samples for high-quality nucleic acid extraction, making it suitable for genomic and epigenetic studies. Its preservation properties ensure reliable downstream molecular analysis, which is critical for accurate genetic testing and research applications.

  • Is the PAXgene Blood DNA Tube intended for reuse, or is it meant to be used only once?

    The PAXgene Blood DNA Tube is explicitly labeled as a single-use device. This design ensures sterility and prevents cross-contamination, which is essential for maintaining the integrity of blood samples for diagnostic purposes.

  • How is the PAXgene Blood DNA Tube supplied, and what preparation is required before use?

    The PAXgene Blood DNA Tube is supplied sterile and pre-labeled, requiring no additional preparation beyond standard blood collection procedures. This simplifies workflows in clinical chemistry settings, ensuring ease of use while maintaining regulatory compliance.

  • What regulatory pathways has the PAXgene Blood DNA Tube followed, and what does this mean for its use?

    The PAXgene Blood DNA Tube has undergone FDA 510(k) clearance and is compliant with the In Vitro Diagnostic Regulation (IVDR). This means it meets stringent standards for safety, performance, and traceability, ensuring reliability for in vitro diagnostic use in clinical chemistry.