Bilirubin Direct Gen.2 (Doumas standardization) 05589061190

GUDID 04015630927531

Roche Diagnostics GmbH

Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Primary Device ID04015630927531
NIH Device Record Key85fffc33-0a90-43bc-a988-c369a8ba841b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBilirubin Direct Gen.2 (Doumas standardization)
Version Model Number05589061190
Catalog Number05589061190
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630927531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CIGDIAZO COLORIMETRY, BILIRUBIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-16
Device Publish Date2023-10-06

On-Brand Devices [Bilirubin Direct Gen.2 (Doumas standardization)]

0401563092753105589061190
0401563092491205168384190

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