Home GUDID 00657498000588 Total Bilirubin LiquiColor®
Primary DI 00657498000588
Brand Total Bilirubin LiquiColor®
Company STANBIO LABORATORY, L.P.
Model 0230-450
Catalog number 0230-450
Device description The Stanbio Total Bilirubin LiquiColor® test system is a device intended to measure the levels of bilirubin (total) in serum and plasma. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
Published 2016-09-23
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 00657498000588 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00657498000588 00657498000588 657498000588 0657498000588
GMDN Terms# Term, Definition table Term Definition Total bilirubin IVD, kit, enzyme spectrophotometry A collection of reagents and other associated materials intended to be used for the quantitative measurement of total bilirubin in a clinical specimen, using an enzyme 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 045361136 Device count 1 Lot or batch true Expiration date on label true Contains natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00657498001950 Procalcitonin LiquiColor 2300-060 2300-060 2017-06-26 00657498000434 Albumin LiquiColor® 0285-500 0285-500 2016-09-23 00657498001516 Sirrus® Albumin LiquiColor® S0285-750 S0285-750 2016-09-23 00657498000847 Glycated Serum Protein (GSP) LiquiColor® 2350-062 2350-062 2016-09-23 00657498002179 STAT-Site WB Dual Analyte Measurement System 7000-001 7000-001 2019-11-18 00657498002193 STAT-Site WB Blood Glucose Test Strips 7010-025 7010-025 2019-11-18 00657498002209 STAT-Site WB Blood Glucose Test Strips 7010-050 7010-050 2019-11-18 00657498002216 STAT-Site WB Blood Glucose Test Strips 7010-100 7010-100 2019-11-18 00657498002230 STAT-Site WB B-Ketone Test Strips 7020-025 7020-025 2019-11-18 00657498002247 STAT-Site WB B-Ketone Test Strips 7020-050 7020-050 2019-11-18 00657498002254 STAT-Site WB B-Ketone Test Strips 7020-100 7020-100 2019-11-18 00657498002261 Blood Glucose Control Solution 7014-204 7014-204 2019-11-18 00657498002278 B-Ketone Control Solution 7024-204 7024-204 2019-11-18 00657498000427 Acetaminophen Liquicolor® 2400-060 2400-060 2016-09-23 00657498000441 Alkaline Phosphatase LiquiColor® 2900-430 2900-430 2016-09-23 00657498000458 Alkaline Phosphatase LiquiColor® 2900-500 2900-500 2016-09-23 00657498000489 a-Amylase LiquiColor® 2970-430 2970-430 2016-09-23 00657498000496 AST/SGOT Liqui-UV® 2920-430 2920-430 2016-09-23 00657498000502 AST/SGOT Liqui-UV® 2920-500 2920-500 2016-09-23 00657498000519 B-Hydroxybutyrate LiquiColor® 2440-058 2440-058 2016-09-23
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 05055273214796 DIRECT BILIRUBIN 2 (D 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 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
ekfdiagnostics.com