N Latex IgG3 OPAV03

GUDID 00842768006708

Quantitative determination of IgG subclass 3 in human serum and plasma on BN II and BN ProSpec® Systems

Siemens Healthcare Diagnostics Products GmbH

Immunoglobulin G subclass (IgG subclass) IVD, reagent
Primary Device ID00842768006708
NIH Device Record Keyc57f1fd0-df79-42c3-b485-fc3b3b5eee96
Commercial Distribution StatusIn Commercial Distribution
Brand NameN Latex IgG3
Version Model Number10445972
Catalog NumberOPAV03
Company DUNS388240673
Company NameSiemens Healthcare Diagnostics Products GmbH
Device Count1
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)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
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
GS100842768006708 [Primary]

FDA Product Code

DASIGG (FC FRAGMENT SPECIFIC), 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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