Atellica IM BR Calibrator 11206237

GUDID 00630414294056

BR Calibrator - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL

Siemens Healthcare Diagnostics Inc.

Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator
Primary Device ID00630414294056
NIH Device Record Key4e3a9d8d-f2e5-4de6-9958-a03d7c8d8077
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtellica IM BR Calibrator
Version Model Number11206237
Catalog Number11206237
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
Device Count2
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
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
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
GS100630414293486 [Primary]
GS100630414294056 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOISYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-31

On-Brand Devices [Atellica IM BR Calibrator]

00630414598420BR Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
00630414294056BR Calibrator - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
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