DImension Vista® Protein 3 Calibrator KC770

GUDID 00842768006449

For the calibration of the A1MIC, CYSC, MALB and sALB (for serum, plasma and cerebrospinal fluid) methods on the Dimension Vista® System

Siemens Healthcare Diagnostics Products GmbH

Plasma protein IVD, calibrator
Primary Device ID00842768006449
NIH Device Record Keydb2ebc62-6745-4782-89e6-7682cbc9431f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDImension Vista® Protein 3 Calibrator
Version Model Number10445931
Catalog NumberKC770
Company DUNS388240673
Company NameSiemens Healthcare Diagnostics Products GmbH
Device Count4
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)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
GS100842768006449 [Primary]
GS100842768019319 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIXCALIBRATOR, MULTI-ANALYTE MIXTURE

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

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00842768019654 - LA 1 Screening Reagent2024-04-08 LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants
00842768019678 - LA Control Low2024-04-08 LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays
00842768019685 - LA Control High2024-04-08 LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays

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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