FDA.reportPublic FDA data

Lipoprotein (a) Kit for use on SPAPLUS

Primary DI
05051700016841
Brand
Lipoprotein (a) Kit for use on SPAPLUS
Company
THE BINDING SITE GROUP LIMITED
Model
LK098.S
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
JISCalibrator, Primary
JJSControls For Blood-Gases, (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DFCLipoprotein, Low-Density, Antigen, Antiserum, ControlImmunology2
JISCalibrator, PrimaryClinical Chemistry2
JJSControls For Blood-Gases, (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011568000RANDOX LIPOPROTEINRandox Laboratories, Ltd.2001-09-28JIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700016841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700016841050517000168415051700016841

GMDN Terms#

Term, Definition table
TermDefinition
Lipoprotein A IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401214569500info@bindingsite.co.uk

Regulatory Flags#

DUNS number
347045614
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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05051700006316Freelite® Human Kappa Free Kit for use on the HITACHI 911/912/917/Modular P LK016.H2016-09-24
05051700006323Freelite® Human Kappa Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®800LK016.IM2016-09-24
05051700006439Freelite® Human Lambda Free Kit for use on the Hitachi 911/912/917/Modular P LK018.H2016-09-24
05051700010269Total Haemolytic Complement RC001.12016-09-24
05051700010276Total Haemolytic Complement RC001.22016-09-24
05051700010283Total Haemolytic Complement RC001.32016-09-24
05051700010399Human IgG Subclass Single Dilution BINDARID™ Kit - Bulk KitRK0212016-09-24
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05051700010917Human IgG1 Subclass Single Dilution BINDARID™ KitsRN106.32016-09-24
05051700010924Human IgG2 Subclass Single Dilution BINDARID™ KitsRN107.32016-09-24
05051700010931Human IgG3 Subclass Single Dilution BINDARID™ KitsRN108.32016-09-24
05051700010948Human IgG3 Subclass Single Dilution BINDARID™ KitsRN109.32016-09-24
05051700016919Hevylite® Human IgA Kappa Kit for use on the Siemens BN™II NK623.T.A2016-09-24
05051700016926Hevylite IgA Lambda Kit for Siemens BNIINK624.T.A2016-09-24
05051700018715 Freelite® Human Lambda Free Control Pack For use on the Beckman Coulter IMMAGE™NQ018.IM2017-06-05
05051700018739 Freelite® Human Kappa Free Control Pack For use on the Beckman Coulter IMMAGE™/NQ016.IM2017-06-05

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