ADVIA Centaur® CA 19-9 DIL

Basic Information

• Brand Name: ADVIA Centaur® CA 19-9 DIL
• Primary DI: 00630414577135
• Version / Model: 10491974
• Catalog Number: 10491974
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-01
• Public Version: 4
• Public Version Date: 2023-06-13
• Public Version Status: Update
• Public Device Record Key: bcf48965-e13a-4377-9f85-3f14536d6ef5

Device Description

CA 19-9 bottle - CENTAUR - CONS - 1x25mL

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NIG	SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER	Immunology	866.6010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58237	Buffered sample diluent IVD	A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414577135	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K031393	000