Magellan Diagnostics, Inc.

Matched from indexed company URL: MAGELLAN DIAGNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1218996	1218996	Magellan Diagnostics, Inc.	1	N	2026-01-01	101 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 GUDID	Product	Phone	Email
00850355006000	LeadCare® II Blood Lead Test Kit - LeadCare® II	800-275-0102	LeadCareSupport@magellandx.com
00850355006017	LeadCare® II Blood Lead Analyzer Kit - LeadCare® II	800-275-0102	LeadCareSupport@magellandx.com
00850355006031	LeadCare® Plus Blood Lead Test Kit - LeadCare® Plus	800-275-0102	LeadCareSupport@magellandx.com
00850355006062	LeadCare® Plus Blood Lead Analyzer Kit - LeadCare® Plus	800-275-0102	LeadCareSupport@magellandx.com
00850355006079	LeadCare® II Blood Lead 6 Tests Kit - LeadCare® II	800-275-0102	LeadCareSupport@magellandx.com
00850355006086	LeadCare® II 5X Test Kit - LeadCare® II Test Kit 5X Test Kit	800-275-0102	LeadCareSupport@magellandx.com
00850355006093	LeadCare® II Blood Lead Testing System 9X Test Kit - LeadCare® II	800-275-0102	LeadCareSupport@magellandx.com
00850355006185	LeadCare® Plus Blood Lead Analyzer Kit - LeadCare® Plus Blood Lead Analyzer Kit Refurbished	800-275-0102	LeadCareSupport@magellandx.com

magellandx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
1351	1744341162	K971640	LEADCARE BLOOD LEAD TESTING SYSTEM	DOF	1997-09-09
1351	1947572430	K142705	LeadCare Plus Blood Lead Testing System	DOF	2015-07-07
1351	1382873686	K123563	LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM	DOF	2013-08-20
1351	1073285649	K052549	LEADCARE II BLOOD LEAD TESTING SYSTEM	DOF	2005-10-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DOF	4	2015-07-07

PMN#

LeadCare Plus Blood Lead Testing System
2015-07-07
Magellan Diagnostics
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
2013-08-20
MAGELLAN DIAGNOSTICS

GUDID#

LeadCare® II 5X Test Kit - LeadCare® II Test Kit 5X Test Kit
MAGELLAN DIAGNOSTICS, INC.
2018-10-22
LeadCare® Plus Blood Lead Analyzer Kit - LeadCare® Plus Blood Lead Analyzer Kit Refurbished
MAGELLAN DIAGNOSTICS, INC.
2018-10-22
LeadCare® II Blood Lead Test Kit - LeadCare® II
MAGELLAN DIAGNOSTICS, INC.
2016-09-19
LeadCare® II Blood Lead Analyzer Kit - LeadCare® II
MAGELLAN DIAGNOSTICS, INC.
2016-09-19
LeadCare® Plus Blood Lead Test Kit - LeadCare® Plus
MAGELLAN DIAGNOSTICS, INC.
2016-09-09
LeadCare® Plus Blood Lead Analyzer Kit - LeadCare® Plus
MAGELLAN DIAGNOSTICS, INC.
2016-09-19
LeadCare® II Blood Lead 6 Tests Kit - LeadCare® II
MAGELLAN DIAGNOSTICS, INC.
2016-09-19
LeadCare® II Blood Lead Testing System 9X Test Kit - LeadCare® II
MAGELLAN DIAGNOSTICS, INC.
2016-09-09
LeadCare® II Blood Lead Testing System 9X ClinicalTest Kit - LeadCare® II
MAGELLAN DIAGNOSTICS, INC.
2016-09-09
LeadCare® Plus Data ManagementSystem - LeadCare®
MAGELLAN DIAGNOSTICS, INC.
2016-09-19
LeadCare® II Replacement AC Adapter and Plug Set - LeadCare® II
MAGELLAN DIAGNOSTICS, INC.
2016-09-19
LeadCare® Heparinized Capillary Tubes - LeadCare®
MAGELLAN DIAGNOSTICS, INC.
2016-09-20
LeadCare® Blood Collection Plungers - LeadCare®
MAGELLAN DIAGNOSTICS, INC.
2016-09-19
LeadCare® Blood Lead Test Kit - LeadCare®
MAGELLAN DIAGNOSTICS, INC.
2016-09-19
LeadCare® Blood Lead Control Kit - LeadCare®
MAGELLAN DIAGNOSTICS, INC.
2016-09-20
LeadCare® II Blood Lead Analyzer Kit, Refurbished - LeadCare® II
MAGELLAN DIAGNOSTICS, INC.
2016-09-20
LeadCare® Ultra Blood Lead Test Kit - LeadCare® Ultra
MAGELLAN DIAGNOSTICS, INC.
2016-09-09
LeadCare® Ultra Blood Lead Analyzer Kit - LeadCare® Ultra
MAGELLAN DIAGNOSTICS, INC.
2016-09-09
LeadCare® Ultra Blood Lead Testing System - LeadCare® Ultra
MAGELLAN DIAGNOSTICS, INC.
2016-09-09