N AS IgG1 OQXI09

GUDID 00842768008450

Quantitative determination of IgG subclass 1 in human serum on BN II and BN ProSpec® Systems

Siemens Healthcare Diagnostics Products GmbH

Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent Immunoglobulin G subclass (IgG subclass) IVD, reagent
Primary Device ID00842768008450
NIH Device Record Key28bbecb2-5668-495b-ad05-a11b08ebd4f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameN AS IgG1
Version Model Number10446168
Catalog NumberOQXI09
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
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100842768008450 [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

Devices Manufactured by Siemens Healthcare Diagnostics Products GmbH

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00842768018909 - Control Plasma N 2024-02-27 Assayed control used to monitor the performance of coagulation assays in the normal range
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

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