Elecsys total PSA 08791716160

GUDID 07613336166000

Roche Diagnostics GmbH

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 ID07613336166000
NIH Device Record Keyb3c9ac42-a7f7-47fd-86a6-4568664ef539
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys total PSA
Version Model Number08791716160
Catalog Number08791716160
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336166000 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-01
Device Publish Date2020-08-24

On-Brand Devices [Elecsys total PSA]

0401563093982407027966190
0761333616600008791716160
0761333616599708791686160
0761333616598008791732190

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