FDA.reportPublic FDA data

DImension Vista® Haptoglobin Flex® reagent cartridge

Primary DI
00842768006111
Brand
DImension Vista® Haptoglobin Flex® reagent cartridge
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10445896
Catalog number
K7042
Device description
For the quantitative measurement of haptoglobin in human serum and plasma on the Dimension Vista® System
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00842768006111PrimaryGS10
00842768020025Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768006111008427680061118427680061110842768006111
00842768020025008427680200258427680200250842768020025

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.

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
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
2
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414285054N Latex ADNase B (USA)10873691108736912020-07-07
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24
00842768017742Washing Solution for Coagulation Analyzers10446684OWZC392016-09-24
00842768024887BFT II Analyzer10458677OVKF0322016-09-24
00630414639703Control Plasma P10873891108738912024-02-19
00630414639772Standard Human Plasma10873907108739072024-03-25
00630414640167Dade Ci-Trol Coagulation Control Level 110873842108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, Low10873833108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 210873843108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, High10873834108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 310873844108738442024-03-25
00630414640747Control Plasma N 10873874108738742024-02-19
00842768003899Dade® Ci-Trol® Heparin Control, Low10445715B4224-502016-09-24

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
05055273203806HAPTOGLOBIN (HP)RANDOX LABORATORIES LIMITEDDAD2019-06-03
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
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