total PSA Calset II 04485220160

GUDID 07613336154380

Total PSA G2 CS Elecsys V2.1

Roche Diagnostics GmbH

Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator
Primary Device ID07613336154380
NIH Device Record Key8998114c-1109-40cc-b081-77d473ec2d3b
Commercial Distribution StatusIn Commercial Distribution
Brand Nametotal PSA Calset II
Version Model Number04485220160
Catalog Number04485220160
Company DUNS315028860
Company NameRoche Diagnostics GmbH
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630920754 [Previous]
GS107613336154380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MTFTotal,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2017-09-29

On-Brand Devices [total PSA Calset II]

07613336154380Total PSA G2 CS Elecsys V2.1
0761333616749608838534160

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