COBAS Acetaminophen Calibrator

Basic Information

• Brand Name: COBAS Acetaminophen Calibrator
• Primary DI: 04015630997145
• Version / Model: 20758809122
• Catalog Number: 20758809122
• 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: 3
• Public Version Date: 2020-11-11
• Public Version Status: Update
• Public Device Record Key: a3b7baa0-fe7f-4ae9-91a2-1e08ed8e77bb
• Distribution End Date: 2018-08-31

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
DLJ	CALIBRATORS, DRUG SPECIFIC	Clinical Toxicology	862.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45778	Acetaminophen IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of acetaminophen in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630997145	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius