FDA.reportPublic FDA data

Serum Protein Electrophoresis (SPE) Kit

Primary DI
05051700011235
Brand
Serum Protein Electrophoresis (SPE) Kit
Company
THE BINDING SITE GROUP LIMITED
Model
XK003
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
CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924767000IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFICThe Binding Site, Ltd.1993-02-23CFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700011235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700011235050517000112355051700011235

GMDN Terms#

Term, Definition table
TermDefinition
Protein electrophoresis IVD, kit, electrophoresisA collection of reagents and other associated materials intended to be used for determining the qualitative and/or quantitative separation of proteins in a clinical specimen, using an electrophoresis 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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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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05051700010948Human IgG3 Subclass Single Dilution BINDARID™ KitsRN109.32016-09-24
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