FDA.reportPublic FDA data

AU

Primary DI
15099590010591
Brand
AU
Company
BECKMAN COULTER IRELAND INC.
Model
OSR6162
Device description
α-1 Acidglycoprotein
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
15099590010591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959001059115099590010591

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985071975
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590695743iChemVELOCITYB793192026-04-27
15099590225889AQUIOS CL B301662016-09-23
15099590677466Navios EX10 Color 3 lasersB809102017-07-06
15099590682996Navios EX8 Color 2 lasersB809112017-07-06
15099590683009Navios EX6 Color 2 lasersB809122017-07-06
15099590683245Navios EXACQUISITION NEW USER SOFTWARE V2.0 WIN 7B91237 2017-07-06
15099590683252Navios EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7 B91238 2017-07-06
15099590683269Navios EXOFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7 B912392017-07-06
15099590683276Navios EXTETRA SOFTWARE V2.0 NEW USER B91240 2017-07-06
15099590671242DxH 500B40601B406012020-08-31
15099590679781DxH 520B406022019-03-22
10837461001065Iris660-3021660-30212025-04-16
10837461002321Iris800-3215800-32152025-04-16
15099590694968ClearLLab 10CB900022019-04-05
15099590694975ClearLLab 10CB900032019-03-26
15099590694982ClearLLab 10CB998832019-03-26
15099590701475ClearLLab 10CB968052019-03-26
15099590701482ClearLLab 10CB968062019-03-26
15099590701499ClearLLab 10CB968072019-03-26
15099590701505ClearLLab 10CB968082019-03-26

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
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
05051700017633Optilite Alpha-1-Acid Glycoprotein KitTHE BINDING SITE GROUP LIMITEDLKL2016-09-24
00816426020146K-ASSAY® Alpha-1 AG ReagentKAMIYA BIOMEDICAL COMPANY, LLCLKL2016-09-16
15099590224066IMMAGEBeckman Coulter, Inc.LKL2016-08-24