FDA.reportPublic FDA data

LeadCare® Plus Data ManagementSystem

Primary DI
00850355006116
Brand
LeadCare® Plus Data ManagementSystem
Company
MAGELLAN DIAGNOSTICS, INC.
Model
LeadCare®
Catalog number
82-0003
Device description
LeadCare® Plus Data ManagementSystem
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DOFLead, Atomic Absorption

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DOFLead, Atomic AbsorptionClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142705000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142705000LeadCare Plus Blood Lead Testing SystemMagellan Diagnostics2015-07-07DOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850355006116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850355006116008503550061168503550061160850355006116

GMDN Terms#

Term, Definition table
TermDefinition
Lead (Pb) analyser IVDAn electrically-powered laboratory instrument intended to be used for the quantitative determination of the heavy metal lead (Pb) in a clinical specimen, using technology which may incorporate fluorometry or electrometry. The analyser requires the use of specific reagents and test strips, packaged together in a test kit. The analyser is intended to be used by health professionals at the point-of-care, and often also in the laboratory.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-275-0102LeadCareSupport@magellandx.com

Regulatory Flags#

DUNS number
078525694
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850355006086LeadCare® II 5X Test KitLeadCare® II 70-84042018-10-22
00850355006185LeadCare® Plus Blood Lead Analyzer KitLeadCare® Plus82-0002-R2018-10-22
00850355006000LeadCare® II Blood Lead Test KitLeadCare® II70-67622016-09-19
00850355006017LeadCare® II Blood Lead Analyzer KitLeadCare® II70-67602016-09-19
00850355006031LeadCare® Plus Blood Lead Test KitLeadCare® Plus82-00042016-09-09
00850355006062LeadCare® Plus Blood Lead Analyzer KitLeadCare® Plus82-00012016-09-19
00850355006079LeadCare® II Blood Lead 6 Tests KitLeadCare® II70-71422016-09-19
00850355006093LeadCare® II Blood Lead Testing System 9X Test KitLeadCare® II70-90002016-09-09
00850355006109LeadCare® II Blood Lead Testing System 9X ClinicalTest KitLeadCare® II80-01612016-09-09
00850355006123LeadCare® II Replacement AC Adapter and Plug SetLeadCare® II82-0001 2016-09-19
00850355006130LeadCare® Heparinized Capillary TubesLeadCare®70-36622016-09-20
00850355006147LeadCare® Blood Collection PlungersLeadCare®70-36632016-09-19
00850355006154LeadCare® Blood Lead Test KitLeadCare®70-22332016-09-19
00850355006161LeadCare® Blood Lead Control KitLeadCare®70-34402016-09-20
00850355006178LeadCare® II Blood Lead Analyzer Kit, RefurbishedLeadCare® II70-65829R2016-09-20
00850355006024LeadCare® Ultra Blood Lead Test KitLeadCare® Ultra70-80982016-09-09
00850355006048LeadCare® Ultra Blood Lead Analyzer KitLeadCare® Ultra2016-09-09
00850355006055LeadCare® Ultra Blood Lead Testing SystemLeadCare® Ultra70-80402016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850355006086LeadCare® II 5X Test KitMAGELLAN DIAGNOSTICS, INC.DOF2018-10-22
00850355006185LeadCare® Plus Blood Lead Analyzer KitMAGELLAN DIAGNOSTICS, INC.DOF2018-10-22
00850355006130LeadCare® Heparinized Capillary TubesMAGELLAN DIAGNOSTICS, INC.DOF2016-09-20
00850355006161LeadCare® Blood Lead Control KitMAGELLAN DIAGNOSTICS, INC.DOF2016-09-20
00850355006178LeadCare® II Blood Lead Analyzer Kit, RefurbishedMAGELLAN DIAGNOSTICS, INC.DOF2016-09-20
00850355006000LeadCare® II Blood Lead Test KitMAGELLAN DIAGNOSTICS, INC.DOF2016-09-19
00850355006017LeadCare® II Blood Lead Analyzer KitMAGELLAN DIAGNOSTICS, INC.DOF2016-09-19
00850355006062LeadCare® Plus Blood Lead Analyzer KitMAGELLAN DIAGNOSTICS, INC.DOF2016-09-19
00850355006079LeadCare® II Blood Lead 6 Tests KitMAGELLAN DIAGNOSTICS, INC.DOF2016-09-19
00850355006123LeadCare® II Replacement AC Adapter and Plug SetMAGELLAN DIAGNOSTICS, INC.DOF2016-09-19
00850355006147LeadCare® Blood Collection PlungersMAGELLAN DIAGNOSTICS, INC.DOF2016-09-19
00850355006154LeadCare® Blood Lead Test KitMAGELLAN DIAGNOSTICS, INC.DOF2016-09-19
00850355006024LeadCare® Ultra Blood Lead Test KitMAGELLAN DIAGNOSTICS, INC.DOF2016-09-09
00850355006031LeadCare® Plus Blood Lead Test KitMAGELLAN DIAGNOSTICS, INC.DOF2016-09-09
00850355006048LeadCare® Ultra Blood Lead Analyzer KitMAGELLAN DIAGNOSTICS, INC.DOF2016-09-09
00850355006055LeadCare® Ultra Blood Lead Testing SystemMAGELLAN DIAGNOSTICS, INC.DOF2016-09-09
00850355006093LeadCare® II Blood Lead Testing System 9X Test KitMAGELLAN DIAGNOSTICS, INC.DOF2016-09-09
00850355006109LeadCare® II Blood Lead Testing System 9X ClinicalTest KitMAGELLAN DIAGNOSTICS, INC.DOF2016-09-09