Elecsys PreciControl Tumor Marker 11776452160

GUDID 04015630938780

Roche Diagnostics GmbH

Multiple tissue-associated protein/tumour marker IVD, control Multiple tissue-associated protein/tumour marker IVD, control Multiple tissue-associated protein/tumour marker IVD, control Multiple tissue-associated protein/tumour marker IVD, control Multiple tissue-associated protein/tumour marker IVD, control Multiple tissue-associated protein/tumour marker IVD, control Multiple tissue-associated protein/tumour marker IVD, control Multiple tissue-associated protein/tumour marker IVD, control Multiple tissue-associated protein/tumour marker IVD, control Multiple tissue-associated protein/tumour marker IVD, control Multiple tissue-associated protein/tumour marker IVD, control Multiple tissue-associated protein/tumour marker IVD, control Multiple tissue-associated protein/tumour marker IVD, control Multiple tissue-associated protein/tumour marker IVD, control
Primary Device ID04015630938780
NIH Device Record Keye218fb8a-c7ea-463e-ae5b-85e7f2529ef6
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys PreciControl Tumor Marker
Version Model Number11776452160
Catalog Number11776452160
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
GS104015630938780 [Primary]
GS104015630938780 [Primary]
GS104015630938780 [Primary]
GS104015630938780 [Primary]
GS104015630938780 [Primary]
GS104015630938780 [Primary]
GS104015630938780 [Primary]
GS104015630938780 [Primary]
GS104015630938780 [Primary]
GS104015630938780 [Primary]
GS104015630938780 [Primary]
GS104015630938780 [Primary]
GS104015630938780 [Primary]
GS104015630938780 [Primary]

FDA Product Code

JJYMulti-analyte controls, all kinds (assayed)
JJYMulti-analyte controls, all kinds (assayed)
JJYMulti-analyte controls, all kinds (assayed)
JJYMulti-analyte controls, all kinds (assayed)
JJYMulti-analyte controls, all kinds (assayed)
JJYMulti-analyte controls, all kinds (assayed)
JJYMulti-analyte controls, all kinds (assayed)
JJYMulti-analyte controls, all kinds (assayed)
JJYMulti-analyte controls, all kinds (assayed)
JJYMulti-analyte controls, all kinds (assayed)
JJYMulti-analyte controls, all kinds (assayed)
JJYMulti-analyte controls, all kinds (assayed)
JJYMulti-analyte controls, all kinds (assayed)
JJYMulti-analyte controls, all kinds (assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-16
Device Publish Date2016-09-20

Devices Manufactured by Roche Diagnostics GmbH

04015630938780 - Elecsys PreciControl Tumor Marker2020-09-16
04015630938780 - Elecsys PreciControl Tumor Marker2020-09-16
07613336166673 - Elecsys free PSA2020-09-04
07613336166628 - Elecsys free PSA2020-09-03
07613336168134 - free PSA CalSet2020-09-03
07613336165980 - Elecsys total PSA2020-09-01
07613336165997 - Elecsys total PSA2020-09-01
07613336166000 - Elecsys total PSA2020-09-01
07613336167496 - total PSA CalSet II2020-09-01

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