FDA.reportPublic FDA data

HAPTOGLOBIN (HP)

Primary DI
05055273203806
Brand
HAPTOGLOBIN (HP)
Company
RANDOX LABORATORIES LIMITED
Model
HP3886
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DADHaptoglobin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DADHaptoglobin, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273203806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273203806050552732038065055273203806

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
227530649
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414610986Atellica CH HAPT2Siemens Healthcare Diagnostics Inc.DAD2023-08-28
00630414305080Atellica CH HAPT2Siemens Healthcare Diagnostics Inc.DAD2023-08-28
00380740169879AlinityABBOTT IRELANDDAD2021-05-13
00380740169886ARCHITECTABBOTT IRELANDDAD2021-03-19
07613336140772Tina-quant Haptoglobin ver.2Roche Diagnostics GmbHDAD2020-03-05
00380740150686AlinityAbbott GmbHDAD2019-07-08
06970291985161Haptoglobin Kit (Immunoturbidimetric Method)Medicalsystem Biotechnology Co., Ltd.DAD2019-03-07
00630414210827Atellica™ CH HaptSiemens Healthcare Diagnostics Inc.DAD2018-12-08
15099590010621AUBeckman Coulter, Inc.DAD2016-09-24
B1761120Antiserum to Human HaptoglobinKENT LABORATORIES INCDAD2016-09-24
05051700016094Human Haptoglobin Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDAD2016-09-24
05051700017626Optilite Haptoglobin KitTHE BINDING SITE GROUP LIMITEDDAD2016-09-24
00842768006111DImension Vista® Haptoglobin Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDAD2016-09-24
00630414491356ADVIA® Chemistry HAPT Haptoglobin ReagentsSiemens Healthcare Diagnostics Inc.DAD2016-09-24
00630414506005ADVIA® Chemistry HAPT Haptoglobin ReagentsSiemens Healthcare Diagnostics Inc.DAD2016-09-24
04015630906765Tinaquant HaptoglobinRoche Diagnostics GmbHDAD2016-09-20
04015630916580Tinaquant Haptoglobin ver2Roche Diagnostics GmbHDAD2016-09-20
04015630928620Tinaquant Haptoglobin ver2Roche Diagnostics GmbHDAD2016-09-20
00816426020153K-ASSAY® Haptoglobin ReagentKAMIYA BIOMEDICAL COMPANY, LLCDAD2016-09-16
10758750002283VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DAD2016-08-26
15099590224431SynchronBeckman Coulter, Inc.DAD2016-08-24
15099590230456IMMAGEBeckman Coulter, Inc.DAD2016-08-24
00380740019693ARCHITECTABBOTT LABORATORIESDAD2016-06-06