FDA.reportPublic FDA data

Optilite Alpha-1-Acid Glycoprotein Kit

Primary DI
05051700017633
Brand
Optilite Alpha-1-Acid Glycoprotein Kit
Company
THE BINDING SITE GROUP LIMITED
Model
NK063.OPT.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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, ControlImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700017633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700017633050517000176335051700017633

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of alpha-1-acid glycoprotein (orosomucoid) 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051700021104Freelite® Human Kappa Free Kit for use on the Roche cobas® c SystemsLK016.CB.A2026-02-02
05051700021111Freelite® Human Lambda Free Kit for use on the Roche cobas® c SystemsLK018.CB.A2026-02-02
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
05051700010504Human C1 Inactivator BINDARID™ Radial Immunodiffusion KitRN019.32016-09-24
05051700010559Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion KitRN025.32016-09-24
05051700010764Human Plasminogen ’NL’ BINDARID™ Radial Immunodiffusion KitRN065.32016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015630919529Tina-quant Alpha 1-Acid Glycoprotein Gen.2Roche Diagnostics GmbHLKL2021-02-08
04015630928408Tina-quant Alpha 1-Acid Glycoprotein Gen.2Roche Diagnostics GmbHLKL2021-01-18
00630414590158ADVIA® Chemistry AAG a1-Acid Glycoprotein ReagentsSiemens Healthcare Diagnostics Inc.LKL2020-09-24
00630414596211Atellica CH AAGSiemens Healthcare Diagnostics Inc.LKL2020-09-24
00842768005985Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHLKL2020-09-24
07613336130162Tina-quant a1-Acid Glycoprotein Gen.2Roche Diagnostics GmbHLKL2020-03-05
00380740156428ARCHITECTABBOTT LABORATORIESLKL2020-03-03
05055273200126ALPHA-1-ACID-GLYCOPROTEIN (AGT)RANDOX LABORATORIES LIMITEDLKL2019-05-31
00380740153809AlinityABBOTT LABORATORIESLKL2019-04-10
00380740054168ARCHITECTABBOTT LABORATORIESLKL2018-07-31
08058056680648alpha 1-Acid GlycoproteinSENTINEL CH. SPALKL2017-05-15
15099590010591AUBECKMAN COULTER IRELAND INC.LKL2016-09-24
B1761230Antiserum to Human Alpha 1 Acid GlycoproteinKENT LABORATORIES INCLKL2016-09-24
05051700016537Human alpha 1 acid glycoprotein Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDLKL2016-09-24
00816426020146K-ASSAY® Alpha-1 AG ReagentKAMIYA BIOMEDICAL COMPANY, LLCLKL2016-09-16
15099590224066IMMAGEBeckman Coulter, Inc.LKL2016-08-24