CAROLINA LIQUID CHEMISTRIES CORP.® TBIL REAGENT PRODUCT NO. DT228

Basic Information

• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® TBIL REAGENT PRODUCT NO. DT228
• Primary DI: 00817302023084
• Version / Model: DT228
• Catalog Number: DT228
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Labeler DUNS: 962385787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-17
• Public Version: 3
• Public Version Date: 2023-08-14
• Public Version Status: Update
• Public Device Record Key: 5ba0f754-9b81-473e-9f7f-cf84b614c02e

Device Description

TBIL (Total Bilirubin) 4 x 300 tests

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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	00817302023084	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	68	Milliliter
Device Size Text, specify			Kit contains 4 R1 bottles, 4 R2 bottles and 1 package insert
Total Volume	12	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
• Type: Storage Environment Temperature
• Temperature Range: 8 – 30 Degrees Celsius