Dimension Vista® a1-Microglobulin Flex® reagent cartridge K7010

GUDID 00842768005978

For the quantitative measurement of a1-microglobulin in human urine on the Dimension Vista® System

Siemens Healthcare Diagnostics Products GmbH

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Primary Device ID00842768005978
NIH Device Record Key747e227d-00f4-4ab7-b5e3-62761e0284c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDimension Vista® a1-Microglobulin Flex® reagent cartridge
Version Model Number10445882
Catalog NumberK7010
Company DUNS388240673
Company NameSiemens Healthcare Diagnostics Products GmbH
Device Count2
DM Exemptfalse
Pre-market Exempttrue
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)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100842768005978 [Primary]
GS100842768019852 [Unit of Use]

FDA Product Code

DCOALPHA-GLOBULIN, ANTIGEN, ANTISERUM, CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-02
Device Publish Date2020-09-24

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00842768018886 - Coagulation Factor V Deficient Plasma2024-02-27 For the determination of the activity of coagulation factor V in human plasma by coagulometric methods
00842768006661 - vWF Ag2023-06-26 For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma
00842768028014 - INNOVANCE VWF Ac2022-10-18 In-vitro diagnostic automated assay for the quantitative determination of the von Willebrandfactor-GPIb-binding activity in huma
00630414287430 - N LP(a) Standard SY2020-10-20 Calibration of Lp(a) assay on BN Systems
00630414287416 - N/T Rheumatology Control SL/12020-10-02 Assayed control for RF, ASL and CRP assays on BN Systems
00630414287423 - N/T Rheumatology Control SL/22020-10-02 Assayed control for RF, ASL and CRP assays on BN Systems

Trademark Results [Dimension Vista]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIMENSION VISTA
DIMENSION VISTA
87350896 5290516 Live/Registered
Siemens Healthcare Diagnostics Inc.
2017-02-27
DIMENSION VISTA
DIMENSION VISTA
78480379 3199475 Live/Registered
SIEMENS HEALTHCARE DIAGNOSTICS INC.
2004-09-08
DIMENSION VISTA
DIMENSION VISTA
76515533 not registered Dead/Abandoned
Dade Behring Inc.
2003-05-19
DIMENSION VISTA
DIMENSION VISTA
76511472 3117538 Dead/Cancelled
Dade Behring Inc.
2003-05-06

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