INNOVANCE® D-Dimer OPBP09

GUDID 00842768022814

For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Sysmex® Coagulation Systems

Siemens Healthcare Diagnostics Products GmbH

D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination D-dimer IVD, kit, agglutination
Primary Device ID00842768022814
NIH Device Record Key8c8b6984-5aa1-459f-9cb4-d1d37a359e67
Commercial Distribution StatusIn Commercial Distribution
Brand NameINNOVANCE® D-Dimer
Version Model Number10445981
Catalog NumberOPBP09
Company DUNS388240673
Company NameSiemens Healthcare Diagnostics Products GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100842768022814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DAPFIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [INNOVANCE® D-Dimer]

00842768022821For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in hum
00842768022814For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in hum

Trademark Results [INNOVANCE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INNOVANCE
INNOVANCE
97178063 not registered Live/Pending
WESCO Distribution, Inc.
2021-12-17
INNOVANCE
INNOVANCE
90346939 not registered Live/Pending
YANTAI WINHERE AUTO-PART MANUFACTURING CO.,LTD.
2020-11-29
INNOVANCE
INNOVANCE
90071044 not registered Live/Pending
GL Biotech Inc.
2020-07-24
INNOVANCE
INNOVANCE
88659375 not registered Live/Pending
Prota Biotech Inc
2019-10-18
INNOVANCE
INNOVANCE
87247972 not registered Dead/Abandoned
Innova Biotech, Inc.
2016-11-25
INNOVANCE
INNOVANCE
78283931 3527541 Live/Registered
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTSGMBH
2003-08-06
INNOVANCE
INNOVANCE
76584588 3159425 Live/Registered
Innovance, Inc.
2004-04-02
INNOVANCE
INNOVANCE
76580855 not registered Dead/Abandoned
Dade Behring Marburg GmbH
2004-03-15
INNOVANCE
INNOVANCE
76217932 not registered Dead/Abandoned
Innovance, Inc.
2001-03-01

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