Atellica IM cPSA MCM

Basic Information

• Brand Name: Atellica IM cPSA MCM
• Primary DI: 00630414598697
• Version / Model: 10995545
• Catalog Number: 10995545
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-14
• Public Version: 6
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 0be99115-75d3-4ac3-85bc-3c7c8b0ba56d

Device Description

Complexed Prostate Specific Antigen (cPSA) - Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL

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
NAF	ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
54676	Complexed prostate specific antigen (cPSA) 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 complexed prostate specific antigen (cPSA) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414598697	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P990055	001
P990055	007
P990055	008
P990055	012
P990055	016
P990055	017

Storage Conditions

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