total PSA Calset II

Basic Information

• Brand Name: total PSA Calset II
• Primary DI: 07613336154380
• Version / Model: 04485220160
• Catalog Number: 04485220160
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-29
• Public Version: 5
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 8998114c-1109-40cc-b081-77d473ec2d3b

Device Description

Total PSA G2 CS Elecsys V2.1

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: Yes
• 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
MTF	Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
38208	Total prostate specific antigen (tPSA) 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 total prostate specific antigen (tPSA) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613336154380	GS1
Previous	04015630920754	GS1

Premarket Submissions

Submission Number	Supplement Number
P990056	024

Storage Conditions

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