Procalcitonin (PCT) Calibrators

Basic Information

• Brand Name: Procalcitonin (PCT) Calibrators
• Primary DI: 00657498001967
• Version / Model: 2310-601
• Catalog Number: 2310-601
• Company Name: STANBIO LABORATORY, L.P.
• Labeler DUNS: 045361136
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-26
• Public Version: 3
• Public Version Date: 2022-08-31
• Public Version Status: Update
• Public Device Record Key: 5d7f54fa-9c3f-4809-a3dd-58406922de6f
• Distribution End Date: 2022-08-30

Device Description

The Stanbio Procalcitonin (PCT) Calibrator Set is intended for use in the calibration of the quantitative Stanbio PCT LiquiColor® Assay.

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
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
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	00657498001967	GS1

Customer Contacts

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

Storage Conditions

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