ClearChem Diagnostics Inc. Bilirubin, Direct

Basic Information

• Brand Name: ClearChem Diagnostics Inc. Bilirubin, Direct
• Primary DI: 00852169008096
• Version / Model: BRD1050
• Catalog Number: BRD1050
• Company Name: CLEARCHEM DIAGNOSTICS INC.
• Labeler DUNS: 010655581
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-30
• Public Version: 1
• Public Version Date: 2018-05-31
• Public Version Status: New
• Public Device Record Key: fbc9246e-a1c0-4c26-a7aa-38b07a5f1fb1

Device Description

In Vitro Diagnostics testing kit R1:3X28mL, R2:3X7mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
53236	Conjugated (direct) bilirubin IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of conjugated (direct) bilirubin in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852169008096	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	105	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Refrigerated
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius