FDA.reportPublic FDA data

INNOVANCE® D-Dimer Sample Diluent

Primary DI
00630414639666
Brand
INNOVANCE® D-Dimer Sample Diluent
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873905
Catalog number
10873905
Device description
For use in conjunction with INNOVANCE D-Dimer to dilute samples
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DAPFIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081732000INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLSSiemens Healthcare Diagnostics2008-10-24DAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414639666PrimaryGS10
00842768019265Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414639666006304146396666304146396660630414639666
00842768019265008427680192658427680192650842768019265

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVDA buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)242-3233CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00842768003905Dade® Ci-Trol® Heparin Control, High10445716B4224-602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816870023892D-Dimer AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DAP2024-09-13
00816870023908D-Dimer AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DAP2024-09-13
00842768019265INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640181INNOVANCE D-Dimer ControlsSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640488INNOVANCE D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640501INNOVANCE D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
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B1761070Antiserum to Human FibrinogenKENT LABORATORIES INCDAP2016-09-24
05056080500041NAREMEL EUROPE LIMITEDDAP2016-09-24
05056080500058NAREMEL EUROPE LIMITEDDAP2016-09-24
00842768003967Dade® DIMERTEST® Latex AssaySiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768003974Dade® DIMERTEST® Latex BeadsSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768004575Acute Care™ D-DIMER CalPakSiemens Healthcare Diagnostics Inc.DAP2016-09-24
00842768004582Stratus® CS Acute Care™ DDMR DilPakSiemens Healthcare Diagnostics Inc.DAP2016-09-24
00842768022814INNOVANCE® D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768022821INNOVANCE® D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768023668INNOVANCE® D-Dimer ControlsSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768027611INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00630414986166Stratus® CS Acute Care™ DDMR TestPakSiemens Healthcare Diagnostics Inc.DAP2016-09-24