Yumizen C1200 Direct Bilirubin

GUDID 03610230006870

HORIBA ABX SAS

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Primary Device ID03610230006870
NIH Device Record Key9799cf97-032c-43d5-8203-26ecf11f73cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameYumizen C1200 Direct Bilirubin
Version Model Number1300023834
Company DUNS273647420
Company NameHORIBA ABX SAS
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103610230006870 [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 Date2020-09-07
Device Publish Date2020-08-28

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03610230004975 - ABX PENTRA CHOLESTEROL CP2023-07-06
03610230004982 - ABX PENTRA BILIRUBIN, DIRECT CP2023-07-06
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