LeadCare® Blood Lead Control Kit 70-3440

GUDID 00850355006161

LeadCare® Blood Lead Control Kit

MAGELLAN DIAGNOSTICS, INC.

Lead (Pb) analyser IVD
Primary Device ID00850355006161
NIH Device Record Key07c27db2-5a98-4346-9f3c-efe54040fc54
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeadCare® Blood Lead Control Kit
Version Model NumberLeadCare®
Catalog Number70-3440
Company DUNS078525694
Company NameMAGELLAN DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-275-0102
EmailLeadCareSupport@magellandx.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850355006161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DOFLead, Atomic Absorption

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

Devices Manufactured by MAGELLAN DIAGNOSTICS, INC.

00850355006086 - LeadCare® II 5X Test Kit2018-11-22 LeadCare® II Test Kit 5X Test Kit
00850355006185 - LeadCare® Plus Blood Lead Analyzer Kit2018-11-22 LeadCare® Plus Blood Lead Analyzer Kit Refurbished
00850355006000 - LeadCare® II Blood Lead Test Kit2018-07-06 LeadCare® II Blood Lead Test Kit
00850355006017 - LeadCare® II Blood Lead Analyzer Kit2018-07-06 LeadCare® II Blood Lead Analyzer Kit
00850355006031 - LeadCare® Plus Blood Lead Test Kit2018-07-06 LeadCare® Plus Blood Lead Test Kit
00850355006062 - LeadCare® Plus Blood Lead Analyzer Kit2018-07-06 LeadCare® Plus Blood Lead Analyzer Kit
00850355006079 - LeadCare® II Blood Lead 6 Tests Kit2018-07-06 LeadCare® II Blood Lead 6 Tests Kit
00850355006093 - LeadCare® II Blood Lead Testing System 9X Test Kit2018-07-06 LeadCare® II Blood Lead Testing System 9X Test Kit

Trademark Results [LeadCare]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LEADCARE
LEADCARE
75095968 2071520 Live/Registered
LEADCARE, INC.
1996-04-29
LEADCARE
LEADCARE
74643355 1987705 Live/Registered
MAGELLAN DIAGNOSTICS, INC.
1995-03-07

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