Syva® Emit® 2000 Cyclosporine Specific Negative Calibrator 6R319UL

GUDID 00842768001475

Emit ® 2000 Cyclosporine Specific Negative Calibrator

Siemens Healthcare Diagnostics Inc.

Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Primary Device ID00842768001475
NIH Device Record Key20d112dc-b7dc-49f5-8e3d-ef11c5d8c619
Commercial Distribution StatusIn Commercial Distribution
Brand NameSyva® Emit® 2000 Cyclosporine Specific Negative Calibrator
Version Model Number10445377
Catalog Number6R319UL
Company DUNS005088112
Company NameSiemens Healthcare Diagnostics Inc.
Device Count3
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)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414024523 [Unit of Use]
GS100842768001475 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKWCYCLOSPORINE

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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Trademark Results [Syva]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYVA
SYVA
98806088 not registered Live/Pending
Siemens Healthcare Diagnostics Inc.
2024-10-17
SYVA
SYVA
98783461 not registered Live/Pending
Syva
2024-10-03
SYVA
SYVA
79210774 5372298 Live/Registered
L-ACOUSTICS
2017-03-30
SYVA
SYVA
76136850 2602378 Live/Registered
SIEMENS HEALTHCARE DIAGNOSTICS INC.
2000-09-28
SYVA
SYVA
74421581 1836538 Live/Registered
SIEMENS HEALTHCARE DIAGNOSTICS INC.
1993-08-04
SYVA
SYVA
74421327 1839210 Dead/Cancelled
SYVA COMPANY
1993-08-04
SYVA
SYVA
74387980 1864604 Live/Registered
Siemens Healthcare Diagnostics Inc.
1993-05-10
SYVA
SYVA
74387976 1909771 Dead/Cancelled
SYVA DIAGNOSTICS HOLDING COMPANY
1993-05-10
SYVA
SYVA
74387813 1820899 Dead/Cancelled
SYVA COMPANY
1993-05-10
SYVA
SYVA
74272364 1761310 Dead/Cancelled
SYVA COMPANY
1992-05-04
SYVA
SYVA
74270082 1765835 Dead/Cancelled
SYVA COMPANY
1992-04-28
SYVA
SYVA
73763803 1548087 Live/Registered
SYVA COMPANY
1988-11-14

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