Atellica IM PSA 10995663

GUDID 00630414599816

Prostate Specific Antigen (PSA) - Atellica IM - RGT - 500T

Siemens Healthcare Diagnostics Inc.

Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Primary Device ID00630414599816
NIH Device Record Key2adda0ac-48c1-45c5-9e3c-1308984415aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtellica IM PSA
Version Model Number10995663
Catalog Number10995663
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
Device Count5
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

Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414007755 [Unit of Use]
GS100630414599816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-06
Device Publish Date2018-11-14

On-Brand Devices [Atellica IM PSA]

00630414599816Prostate Specific Antigen (PSA) - Atellica IM - RGT - 500T
00630414599809Prostate Specific Antigen (PSA) - Atellica IM - RGT - 100T
00630414294230Prostate Specific Antigen (PSA) - Atellica IM - RGT - 500T
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