Home GUDID 05055273214796 DIRECT BILIRUBIN 2 (D BIL 2)
Primary DI 05055273214796
Brand DIRECT BILIRUBIN 2 (D BIL 2)
Company RANDOX LABORATORIES LIMITED
Model BR8376
Device description The Direct Bilirubin test system is a device intended for the quantitative in vitro determination of Direct Bilirubin in serum and plasma.
Published 2022-10-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name JFM Enzymatic Method, Bilirubin
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JFM Enzymatic Method, Bilirubin Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05055273214796 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05055273214796 05055273214796 5055273214796
GMDN Terms# Term, Definition table Term Definition Conjugated (direct) bilirubin IVD, kit, spectrophotometry A collection of reagents and other associated materials intended to be used for the quantitative measurement of conjugated (direct) bilirubin in a clinical specimen, using a spectrophotometry method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 227530649 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05055273214772 TOTAL BILIRUBIN 2 (T BIL 2) RANDOX LABORATORIES LIMITED JFM 2022-10-04 00630414595801 Atellica CH DBil_2 Siemens Healthcare Diagnostics Inc. JFM 2017-12-26 00630414595818 Atellica CH TBil_2 Siemens Healthcare Diagnostics Inc. JFM 2017-12-21 00630414513058 ADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents Siemens Healthcare Diagnostics Inc. JFM 2016-09-24 00630414513065 ADVIA® Chemistry Direct Bilirubin_2 DBIL_2 Reagents Siemens Healthcare Diagnostics Inc. JFM 2016-09-24 00630414513072 ADVIA® Chemistry TBIL_2 Total Bilirubin_2 Reagents Siemens Healthcare Diagnostics Inc. JFM 2016-09-24 00630414513089 ADVIA® Chemistry DBIL_2 Direct Bilirubin 2 Reagents Siemens Healthcare Diagnostics Inc. JFM 2016-09-24 00657498000564 Direct Bilirubin LiquiColor® STANBIO LABORATORY, L.P. JFM 2016-09-23 00657498000588 Total Bilirubin LiquiColor® STANBIO LABORATORY, L.P. JFM 2016-09-23 00657498001486 Sirrus® Total Bilirubin LiquiColor® STANBIO LABORATORY, L.P. JFM 2016-09-23 00657498001493 Sirrus® Direct Bilirubin LiquiColor® STANBIO LABORATORY, L.P. JFM 2016-09-23 05055273208306 T BIL RANDOX LABORATORIES LIMITED JFM 2016-09-16 05055273208313 D BIL RANDOX LABORATORIES LIMITED JFM 2016-09-16 05055273208320 D BIL RANDOX LABORATORIES LIMITED JFM 2016-09-16 05055273208337 T BIL RANDOX LABORATORIES LIMITED JFM 2016-09-16 15099590222642 Synchron Beckman Coulter, Inc. JFM 2016-08-24
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