DiaSys Procalcitonin FS

Basic Information

• Brand Name: DiaSys Procalcitonin FS
• Primary DI: 04051839013668
• Version / Model: 173189943018
• Catalog Number: 173189943018
• Company Name: DiaSys Diagnostic Systems GmbH
• Labeler DUNS: 328419718
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-01
• Public Version: 2
• Public Version Date: 2026-02-09
• Public Version Status: Update
• Public Device Record Key: c35ae106-4ec9-4448-8413-4e8ece10a250

Device Description

Diagnostic reagent for quantitative in vitro determination of procalcitonin (PCT) in human serum or lithium heparin plasma

Device Characteristics

• Single Use: No
• 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
PTF	Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission	Microbiology	866.3215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54316	Procalcitonin (PCT) IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of procalcitonin (PCT) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04051839013668	GS1

Premarket Submissions

Submission Number	Supplement Number
K242294	000

Storage Conditions

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