Atellica CH IgG_2 11097616

GUDID 00630414596266

Immunoglobulin G (IgG_2) Atellica CH - RGT 720T

Siemens Healthcare Diagnostics Inc.

Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
Primary Device ID00630414596266
NIH Device Record Key582a9c07-3f2c-4359-91ac-40d35cc99b83
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtellica CH IgG_2
Version Model Number11097616
Catalog Number11097616
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
Device Count1
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(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
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
GS100630414596266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CFNMETHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)

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 Date2017-12-27

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