Elecsys free PSA 08828610190

GUDID 07613336166628

Roche Diagnostics GmbH

Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control
Primary Device ID07613336166628
NIH Device Record Key7d27d66c-b8ed-4dcc-918a-6d4e4bd493fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys free PSA
Version Model Number08828610190
Catalog Number08828610190
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 Datefalse
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
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
GS107613336166628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MTGTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-03
Device Publish Date2020-08-26

On-Brand Devices [Elecsys free PSA]

0401563094001107027320190
0761333616662808828610190
0761333616667308828601160

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