Elecsys PreciControl Tumor Marker

Basic Information

• Brand Name: Elecsys PreciControl Tumor Marker
• Primary DI: 04015630938780
• Version / Model: 11776452160
• Catalog Number: 11776452160
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 4
• Public Version Date: 2020-09-16
• Public Version Status: Update
• Public Device Record Key: e218fb8a-c7ea-463e-ae5b-85e7f2529ef6

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
JJY	Multi-analyte controls, all kinds (assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38220	Multiple tissue-associated protein/tumour marker IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple proteins or tumour markers associated with specific tissues in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630938780	GS1

Storage Conditions

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