Atellica IM CA 15-3® Calibrator

Basic Information

• Brand Name: Atellica IM CA 15-3® Calibrator
• Primary DI: 00630414598147
• Version / Model: 10995487
• Catalog Number: 10995487
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2017-12-22
• Public Version: 7
• Public Version Date: 2023-08-10
• Public Version Status: Update
• Public Device Record Key: b3cf18f5-f111-4678-bd0c-f8650df6b2a5

Device Description

CA 15-3® - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL

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
MOI	SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR	Immunology	866.6010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38223	Cancer antigen 15-3 (CA15-3) 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 cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414598147	GS1
Unit of Use	00630414190655	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K012357	000
K192777	000

Storage Conditions

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