GENCHEM™ Direct Bilirubin Reagent

Basic Information

• Brand Name: GENCHEM™ Direct Bilirubin Reagent
• Primary DI: 00851445007198
• Version / Model: GEN-DBILI R1
• Catalog Number: GEN-DBILI R1
• Company Name: GENCHEM INC
• Labeler DUNS: 193856866
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 4
• Public Version Date: 2022-10-21
• Public Version Status: Update
• Public Device Record Key: 8261210f-87f0-400d-8859-8a53984b3d11
• Distribution End Date: 2020-08-19

Device Description

10/17/2022

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
53232	Conjugated (direct) bilirubin IVD, kit, enzyme 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 an enzyme spectrophotometry method.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851445007198	GS1

Customer Contacts

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