Elecsys Free PSA CalCheck

Basic Information

• Brand Name: Elecsys Free PSA CalCheck
• Primary DI: 04015630997053
• Version / Model: 03500373190
• Catalog Number: 03500373190
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-12-18
• Public Version: 8
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 55a93921-58e7-433a-bf9b-03aa0ce890b4
• Distribution End Date: 2019-02-28

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
MTG	TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
38182	Free (unbound) prostate specific antigen (fPSA) 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 free (unbound) prostate specific antigen (fPSA) in any of the isoforms [i.e., benign PSA (BPSA), inactive/intact PSA, and/or the PSA precursor, proPSA] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630997053	GS1

Premarket Submissions

Submission Number	Supplement Number
P000027	000
P000027	001
P000027	005
P000027	006
P000027	012
P000027	027

Storage Conditions

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