FDA.reportPublic FDA data

INNOVANCE D-Dimer

Primary DI
00630414640501
Brand
INNOVANCE D-Dimer
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873853
Catalog number
10873853
Device description
For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Sysmex® Coagulation Systems
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
K093626000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093626000INNOVANCE D-DIMER, MODEL OPBP09Siemens Healthcare Diagnostics2010-11-29DAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414640501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414640501006304146405016304146405010630414640501

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)242-3233CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414634210INNOVANCE D-Dimer 2.0 Diluent10873807108738072026-08-19
00630414656069INNOVANCE D-Dimer 2.0 DILUENT10874094108740942026-08-19
00630414976341Dade® Sickle-Sol Test10459400104594002016-09-24
00630414976358Dade® Sickle-Trol Hemoglobin Controls10459401104594012016-09-24
00630414976365Dade® Sickle-Sol Test10459402104594022016-09-24
00630414634029INNOVANCE D-Dimer 2.010873803108738032026-08-19
00630414634234INNOVANCE D-Dimer 2.0 Control 310873806108738062026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 210873805108738052026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 110873804108738042026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 110874091108740912026-08-19
00630414656014INNOVANCE D-Dimer 2.010874090108740902026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 210874092108740922026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 310874093108740932026-08-19
00630414312446N FLC Supplementary Reagent10873769108737692026-06-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414634029INNOVANCE D-Dimer 2.0Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414634210INNOVANCE D-Dimer 2.0 DiluentSiemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414634234INNOVANCE D-Dimer 2.0 Control 3Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 2Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 1Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 1Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414656014INNOVANCE D-Dimer 2.0Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 2Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 3Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414656069INNOVANCE D-Dimer 2.0 DILUENTSiemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00816870023878D-Dimer AccuLite CLIA Test System - 192 WellsMONOBIND, INC.DAP2024-09-13
00816870023885D-Dimer AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DAP2024-09-13
00816870023892D-Dimer AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DAP2024-09-13
00816870023908D-Dimer AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DAP2024-09-13
00630414639666INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
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
05056080501666Thrombo-Wellcotest Glycine SalineREMEL EUROPE LIMITEDDAP2021-07-21
08426951391615HemosIL D-Dimer HS 500INSTRUMENTATION LABORATORY COMPANYDAP2019-06-10
00895160002502Fluoro-CheckTM D-DimerNANO-DITECH CORPORATIONDAP2019-05-24
30014613337959TriageQUIDEL CARDIOVASCULAR INC.DAP2018-11-01
30014613338000TriageQUIDEL CARDIOVASCULAR INC.DAP2018-11-01
30014613338017TriageQUIDEL CARDIOVASCULAR INC.DAP2018-11-01
00817089020542DiazymeDIAZYME LABORATORIES, INC.DAP2016-11-03
00893038002326Alere Triage®Alere San Diego, Inc.DAP2016-09-26
00899722002733Alere Triage®Alere San Diego, Inc.DAP2016-09-26
00899722002740Alere Triage®Alere San Diego, Inc.DAP2016-09-26
B1761070Antiserum to Human FibrinogenKENT LABORATORIES INCDAP2016-09-24
05056080500041NAREMEL EUROPE LIMITEDDAP2016-09-24