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EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748)

by Stemcell Technologies Canada Inc Canada EUDAMED510(k)

510(k) DEN220090 Product code QYO

Overview

The EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748) is a Hematopoietic Cell Enrichment Kit designed for the positive selection of CD138-positive cells from human bone marrow. This kit leverages magnetic cell separation technology to isolate plasma cells, enabling research and diagnostic applications in immunology and hematology.

The kit is supplied as a single-use reagent system for in vitro laboratory use and requires no specialized equipment beyond standard magnetic separation devices. Sterility is not specified, and the device is classified under FDA regulation 866.6120 as a Class II device, with FDA 510(k) clearance and IVDR conformity. Storage conditions are not detailed but are typically maintained at 2–8°C until use.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG 510(k) De Novo granted · Direct NumberDEN220090 Date6 Nov 2023DecidedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA De Novo Active

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 25 Oct 2026

510(k) Number
FDA Product Code
QYO
FDA applicant
Stemcell Technologies Canada, Inc.
Device Class
Class II
Regulation
21 CFR Part 866.6120
Advisory Committee
Immunology
FDA Decision
DENG De Novo granted

Other devices from Stemcell Technologies Canada Inc

Properties & raw data

Show properties, registry sources and raw records

Sources (2)

  • FDA 510(k) DEN220090 24 fields · synced 25 Oct 2026
  • EUDAMED 1 fields · synced 19 May 2026