Magellan Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for Magellan Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1218996
• FEI Number: 1218996
• Name: Magellan Diagnostics, Inc.
• Owner & Operator: MAGELLAN Diagnostics INC.
• Contact Address: 101 Billerica Ave Bldg 4 --; N Billerica MA 01862 US
• Official Correspondent:
  • Charles G Thornton
  • x-513-2713700-676
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 101 Billerica Ave Bldg 4 ; N Billerica, MA 01862 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 00850355006185 MAGELLAN DIAGNOSTICS, INC.	LeadCare® Plus Blood Lead Analyzer Kit 82-0002-R	2018-11-22
GUDID 00850355006086 MAGELLAN DIAGNOSTICS, INC.	LeadCare® II 5X Test Kit 70-8404	2018-11-22
GUDID 00850355006178 MAGELLAN DIAGNOSTICS, INC.	LeadCare® II Blood Lead Analyzer Kit, Refurbished 70-65829R	2018-07-06
GUDID 00850355006161 MAGELLAN DIAGNOSTICS, INC.	LeadCare® Blood Lead Control Kit 70-3440	2018-07-06
GUDID 00850355006154 MAGELLAN DIAGNOSTICS, INC.	LeadCare® Blood Lead Test Kit 70-2233	2018-07-06
GUDID 00850355006147 MAGELLAN DIAGNOSTICS, INC.	LeadCare® Blood Collection Plungers 70-3663	2018-07-06
GUDID 00850355006130 MAGELLAN DIAGNOSTICS, INC.	LeadCare® Heparinized Capillary Tubes 70-3662	2018-07-06
GUDID 00850355006123 MAGELLAN DIAGNOSTICS, INC.	LeadCare® II Replacement AC Adapter and Plug Set 82-0001	2018-07-06
GUDID 00850355006116 MAGELLAN DIAGNOSTICS, INC.	LeadCare® Plus Data ManagementSystem 82-0003	2018-07-06
GUDID 00850355006109 MAGELLAN DIAGNOSTICS, INC.	LeadCare® II Blood Lead Testing System 9X ClinicalTest Kit 80-0161	2018-07-06
GUDID 00850355006093 MAGELLAN DIAGNOSTICS, INC.	LeadCare® II Blood Lead Testing System 9X Test Kit 70-9000	2018-07-06
GUDID 00850355006079 MAGELLAN DIAGNOSTICS, INC.	LeadCare® II Blood Lead 6 Tests Kit 70-7142	2018-07-06
GUDID 00850355006062 MAGELLAN DIAGNOSTICS, INC.	LeadCare® Plus Blood Lead Analyzer Kit 82-0001	2018-07-06
GUDID 00850355006031 MAGELLAN DIAGNOSTICS, INC.	LeadCare® Plus Blood Lead Test Kit 82-0004	2018-07-06
GUDID 00850355006017 MAGELLAN DIAGNOSTICS, INC.	LeadCare® II Blood Lead Analyzer Kit 70-6760	2018-07-06
GUDID 00850355006000 MAGELLAN DIAGNOSTICS, INC.	LeadCare® II Blood Lead Test Kit 70-6762	2018-07-06
GUDID 00850355006055 MAGELLAN DIAGNOSTICS, INC.	LeadCare® Ultra Blood Lead Testing System 70-8040	2018-03-29
GUDID 00850355006048 MAGELLAN DIAGNOSTICS, INC.	LeadCare® Ultra Blood Lead Analyzer Kit	2018-03-29
GUDID 00850355006024 MAGELLAN DIAGNOSTICS, INC.	LeadCare® Ultra Blood Lead Test Kit 70-8098	2018-03-29
PMN K142705 | DOF Magellan Diagnostics, Inc. [MAGELLAN Diagnostics INC.]	LeadCare Plus	2015-11-11
PMN K123563 | DOF Magellan Diagnostics, Inc. [MAGELLAN Diagnostics INC.]	LeadCare Ultra	2013-11-21
PMN K971640 | DOF Magellan Diagnostics, Inc. [MAGELLAN Diagnostics INC.]	LeadCare Blood Lead Testing System	2007-10-10
PMN K052549 | DOF Magellan Diagnostics, Inc. [MAGELLAN Diagnostics INC.]	LeadCare II Blood Lead Testing Syst	2007-10-10

Related Finance Registrations

NCAGE Code	6ZPQ4	MAGELLAN DIAGNOSTICS, INC.!DBA MAGELLAN DIAGNOSTICS
CAGE Code	6ZPQ4	MAGELLAN DIAGNOSTICS, INC. MAGELLAN DIAGNOSTICS
S.A.M. Registration	6ZPQ4 [78525694]	MAGELLAN DIAGNOSTICS, INC. MAGELLAN DIAGNOSTICS
S.A.M. Registration	6ZPQ4 [78525694]	MAGELLAN DIAGNOSTICS, INC. MAGELLAN DIAGNOSTICS

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020061643278	Genova,Italy -> New York/Newark Area, Newark, New Jersey	TUBE CAP	14 PKG
2020040920065	Genova,Italy -> New York, New York	TUBE CAP	8 PKG
2020040334123	Genova,Italy -> New York, New York	TUBE CAP	8 PKG
2019032928971	Genova,Italy -> New York/Newark Area, Newark, New Jersey	TUBE CAP	6 PKG
2019032639098	Genova,Italy -> New York/Newark Area, Newark, New Jersey	TUBE CAP	6 PKG
2019031124961	Genova,Italy -> New York/Newark Area, Newark, New Jersey	TUBE CAP	6 PKG
2019030445564	Genova,Italy -> New York/Newark Area, Newark, New Jersey	TUBE CAP	5 PKG
2019030135644	Genova,Italy -> New York/Newark Area, Newark, New Jersey	TUBE CAP	6 PKG