Home GUDID 00816068020054 Advanced Instruments BR2 Bilirubin Stat-Analyzer
Primary DI 00816068020054
Brand Advanced Instruments BR2 Bilirubin Stat-Analyzer
Company Advanced Instruments, LLC
Model BR2
Catalog number BR2
Device description For In Vitro Diagnostic Use. Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) and DIRECT (DBR) bilirubin in neonatal serum or plasma.
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name CIG Diazo Colorimetry, Bilirubin
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CIG Diazo Colorimetry, Bilirubin Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816068020054 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 00816068020054 00816068020054 816068020054 0816068020054
GMDN Terms# Term, Definition table Term Definition Bilirubinometer IVD A mains electricity (AC-powered) laboratory instrument designed to determine, by direct or indirect measurement, the concentration of bilirubin in the blood or other clinical specimen most commonly to rapidly assess hyperbilirubinemia in neonates. It typically performs the measurement using spectrophotometry or haemofluorometry.
Regulatory Flags# DUNS number 125006353 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00816068020900 Advanced Instruments Anoxomat III Anaerobic Culture System (100V - 120V) Anoxomat III (100V - 120V) Anoxomat III (100V - 120V) 2020-09-21 00816068020917 Advanced Instruments Ergonomic Culture Jar, Small AJ9049 AJ9049 2020-09-21 00816068020924 Advanced Instruments Ergonomic Culture Jar, Large AJ9050 AJ9050 2020-09-21 00816068020948 Advanced Instruments Standard Anoxomat Jar, Medium AJ9025 AJ9025 2020-09-21 00816068020955 Advanced Instruments Standard Anoxomat Jar, Large AJ9028 AJ9028 2020-09-21 00816068020962 Advanced Instruments Palladox Disposable Satchet AN3146 AN3146 2020-09-21 00816068020023 Advanced Instruments BR2 Disposable Cuvettes B2A800 B2A800 2016-09-23 00816068020030 Advanced Instruments BR2 Total Bilirubin Test Kit, Reagents, and Cuvettes B2A101 B2A101 2016-09-23 00816068020047 Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and Cuvettes B2A102 B2A102 2016-09-23 00816068020078 Advanced Instruments BR2 Sample Diluent B2A101D 2016-09-23 00816068020085 Advanced Instruments BR2 20 mg/dL Bilirubin Equivalent Solution B2A101H 2016-09-23 00816068020092 Advanced Instruments BR2 5mg/dL Bilirubin Equivalent Solution B2A101L 2016-09-23 00816068020108 Advanced Instruments BR2 Sodium Nitrite B2A102N 2016-09-23 00816068020115 Advanced Instruments BR2 Sulfanilic Acid B2A102S 2016-09-23 00816068020122 Advanced Instruments BR2 Hydrochloric Acid B2A102Y 2016-09-23 10816068020174 Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene 800097 800097 2016-09-23 10816068020211 Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit 111011 111011 2016-09-23 00816068020535 Advanced Instruments RBC Reagent Filtration Kit 111014 111014 2021-05-21 00816068020856 Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit 111280 111280 2020-07-21 20816068020201 Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays 111010 111010 2016-09-23
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