FDA.report

Human IgG4 SPA PLUS Bulk Kit

Primary DI
05051700017978
Brand
Human IgG4 SPA PLUS Bulk Kit
Company
THE BINDING SITE GROUP LIMITED
Model
LK009.10S.A
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)

Product Code Classifications

CodeDeviceSpecialtyClass
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)Immunology2

Premarket Submissions

SubmissionSupplement
K072889000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K072889000HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSERThe Binding Site, Ltd.2008-02-01CFN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05051700017978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05051700017978050517000179785051700017978

GMDN Terms

TermDefinition
Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple immunoglobulin G subclasses (IgG subclasses) in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+4401214569500info@bindingsite.co.uk

Regulatory Flags

DUNS number
347045614
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05051700020183Optilite IgM CSF KitTHE BINDING SITE GROUP LIMITEDCFN2020-01-31
05051700020190Optilite IgA CSF KitTHE BINDING SITE GROUP LIMITEDCFN2019-06-21
00630414596266Atellica CH IgG_2Siemens Healthcare Diagnostics Inc.CFN2017-12-27
00630414595627Atellica CH IgM_2Siemens Healthcare Diagnostics Inc.CFN2017-12-21
00630414595610Atellica CH IgA_2Siemens Healthcare Diagnostics Inc.CFN2017-12-19
05051700019835Optilite IgG CSF KitTHE BINDING SITE GROUP LIMITEDCFN2017-05-26
15099590011574AUBeckman Coulter, Inc.CFN2016-09-24
15099590011581AUBeckman Coulter, Inc.CFN2016-09-24
15099590011598AUBeckman Coulter, Inc.CFN2016-09-24
05051700006033Human IgG Subclass Liquid Reagent Kit for use on tTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006088Human IgG Subclass Liquid Reagent Kit for use on tTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
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05051700006187Human IgG4 Subclass Liquid Reagent Kit for use on THE BINDING SITE GROUP LIMITEDCFN2016-09-24
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