FDA.reportPublic FDA data

Magellan Diagnostics, Inc.

Matched from indexed company URL: MAGELLAN DIAGNOSTICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12189961218996Magellan Diagnostics, Inc.1N2026-01-01101 Billerica Ave Bldg 4 N Billerica MA US 01862

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850355006086LeadCare® II 5X Test Kit - LeadCare® II Test Kit 5X Test Kit800-275-0102LeadCareSupport@magellandx.com
00850355006123LeadCare® II Replacement AC Adapter and Plug Set - LeadCare® II800-275-0102LeadCareSupport@magellandx.com
00850355006130LeadCare® Heparinized Capillary Tubes - LeadCare®800-275-0102LeadCareSupport@magellandx.com
00850355006147LeadCare® Blood Collection Plungers - LeadCare®800-275-0102LeadCareSupport@magellandx.com
00850355006154LeadCare® Blood Lead Test Kit - LeadCare®800-275-0102LeadCareSupport@magellandx.com
00850355006161LeadCare® Blood Lead Control Kit - LeadCare®800-275-0102LeadCareSupport@magellandx.com
00850355006178LeadCare® II Blood Lead Analyzer Kit, Refurbished - LeadCare® II800-275-0102LeadCareSupport@magellandx.com
00850355006185LeadCare® Plus Blood Lead Analyzer Kit - LeadCare® Plus Blood Lead Analyzer Kit Refurbished800-275-0102LeadCareSupport@magellandx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
13511744341162K971640LEADCARE BLOOD LEAD TESTING SYSTEMDOF1997-09-09
13511947572430K142705LeadCare Plus Blood Lead Testing SystemDOF2015-07-07
13511382873686K123563LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEMDOF2013-08-20
13511073285649K052549LEADCARE II BLOOD LEAD TESTING SYSTEMDOF2005-10-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DOF42015-07-07

PMN#

GUDID#