Skip to content

LeadCare® Blood Collection Plungers

by Magellan Diagnostics, Inc. FDA registration: United States GUDID

Product code DOF

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850355006147 UDI-DIDate19 Sep 2016ListedStatusIn distribution

Coverage

1 jurisdiction

United 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 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 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 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 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

United States — GUDID listing Listed

Recalls

3 recalls · FDA

    • Terminated Z-0285-2019 FDA Class II initiated 8 Aug 2018

    Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 g/dL). Results for patient testing with this lot will be displayed as HIGH.

    • Terminated Z-2225-2017 FDA Class I initiated 23 May 2017

    Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems

    • Terminated Z-0914-05 FDA Unclassified (pre-2012) initiated 19 May 2005

    Lead test results may be reported lower than the actual value

Specification

GUDID · synced 21 Oct 2026

Generic Name
Lead (Pb) analyser IVD
Model / Ref / Catalog
LeadCare®, 70-3663
Primary DI / UDI-DI
00850355006147
510(k) Number
FDA Product Code
DOF
GMDN Term
Lead (Pb) analyser IVD
Device Class
Class II
Regulation Number
862.3550
Commercial Distribution
In Commercial Distribution

Related devices

Category: Lead (Pb) analyser IVD

Cleared under the same submission (K971640)

Other devices from Magellan Diagnostics, Inc.

See all devices from Magellan Diagnostics, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Prescription Use
  • Lot / Batch Number
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI e642cd87-96f7-46c8-904d-592ede44714a 36 fields · synced 21 Oct 2026