Advanced Instruments BR2 Bilirubin Stat-Analyzer

Basic Information

• Brand Name: Advanced Instruments BR2 Bilirubin Stat-Analyzer
• Primary DI: 00816068020054
• Version / Model: BR2
• Catalog Number: BR2
• Company Name: ADVANCED INSTRUMENTS, INC.
• Labeler DUNS: 125006353
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: cc267749-dfaa-49b3-8db7-90fb37150049

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	862.1110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47988	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816068020054	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]