Direct Bilirubin

Basic Information

• Brand Name: Direct Bilirubin
• Primary DI: 04015630991150
• Version / Model: 11986660018
• Catalog Number: 11986660018
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 5
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: f4513d17-b759-4152-86d1-d9c33dcc90ff
• Distribution End Date: 2019-11-05

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
53229	Total bilirubin IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total bilirubin in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630991150	GS1

Premarket Submissions

Submission Number	Supplement Number
K981883	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius