FDA.reportPublic FDA data

LeadCare® II Blood Lead Testing System 9X Test Kit

Primary DI
00850355006093
Brand
LeadCare® II Blood Lead Testing System 9X Test Kit
Company
MAGELLAN DIAGNOSTICS, INC.
Model
LeadCare® II
Catalog number
70-9000
Device description
LeadCare® II Blood Lead Testing System 9X Test Kit
Published
2016-09-09
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
K052549000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052549000LEADCARE II BLOOD LEAD TESTING SYSTEMEsa Biosciences, Inc.2005-10-06DOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850355006093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850355006093008503550060938503550060930850355006093

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature60 Degrees Fahrenheit80 Degrees Fahrenheit
Special Storage Condition, Specify00Keep sensors sealed in their container until the sample is prepared and you are ready to perform the test. The container is lined with desiccant to keep the sensors fresh.
Special Storage Condition, Specify00Store away from direct sunlight.
Special Storage Condition, Specify00Store in a cool, dry place. Do NOT freeze or refrigerate.
Storage Environment Temperature60 Degrees Fahrenheit80 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
078525694
Device count
1
Kit
true
Lot or batch
true
Expiration 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
00850355006109LeadCare® II Blood Lead Testing System 9X ClinicalTest KitLeadCare® II80-01612016-09-09
00850355006116LeadCare® Plus Data ManagementSystemLeadCare®82-00032016-09-19
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
00850355006116LeadCare® Plus Data ManagementSystemMAGELLAN 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
00850355006109LeadCare® II Blood Lead Testing System 9X ClinicalTest KitMAGELLAN DIAGNOSTICS, INC.DOF2016-09-09