TruCal Procalcitonin Calibrator Set

Basic Information

• Brand Name: TruCal Procalcitonin Calibrator Set
• Primary DI: 04051839013682
• Version / Model: 173109943082
• Catalog Number: 173109943082
• 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: 1
• Public Version Date: 2025-08-11
• Public Version Status: New
• Public Device Record Key: 6169950f-97d6-4a81-ae01-8bd34638c6cd

Device Description

The TruCal Procalcitonin Calibrator Set is intended for in vitro use for calibration of the DiaSys Procalcitonin FS assay

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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54314	Procalcitonin (PCT) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement 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	04051839013682	GS1

Premarket Submissions

Submission Number	Supplement Number
K242294	000

Storage Conditions

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