Calibrant

Basic Information

• Brand Name: Calibrant
• Primary DI: 00850010566061
• Version / Model: 00436
• Catalog Number: 00436
• Company Name: AGENA BIOSCIENCE, INC.
• Labeler DUNS: 079436896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-09-08
• Public Version: 1
• Public Version Date: 2020-09-16
• Public Version Status: New
• Public Device Record Key: a7c0000f-84b5-4f28-b403-0953759fb2c7

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Manufacturing Date: Yes
• 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
DOP	MASS SPECTROMETER, CLINICAL USE	Clinical Chemistry	862.2860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53685	Complement components C3/C3c IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of complement cascade components C3 and/or C3c in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10850010566068	GS1
Primary	00850010566061	GS1

Customer Contacts

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