ADVIA Centaur® H2n MCM

Basic Information

• Brand Name: ADVIA Centaur® H2n MCM
• Primary DI: 00630414469850
• Version / Model: 10324496
• Catalog Number: 131217
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 5faf2b95-cb28-4892-96f6-879a36126604

Device Description

HER-2/NEU Master Curve Material - CENTAUR - CONS

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: 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
NCW	SYSTEM, TEST, HER-2/NEU, MONITORING	Immunology	866.6010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57049	C-erbB2/Her2/neu oncoprotein IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414469850	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K024017	000

Storage Conditions

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