Stratus CS Acute Care CCRP CalPak

Basic Information

• Brand Name: Stratus CS Acute Care CCRP CalPak
• Primary DI: 00842768004476
• Version / Model: 10445067
• Catalog Number: CCCRP-C
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 557b444e-9692-4c7e-bcaa-cf1df16a09f8

Device Description

The Stratus® CS Acute Care™ CardioPhase® High Sensitivity C-reactive Protein Calibrator (CCRP CalPak) is an in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus® CS analyzer.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
JHX	FLUOROMETRIC METHOD, CPK OR ISOENZYMES	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58768	C-reactive protein (CRP) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen, using a fluorescent immunoassay method [includes high-sensitivity CRP (hsCRP) types]. CRP is a marker associated with bacterial infection, inflammatory conditions, and cardiovascular disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768004476	GS1
Unit of Use	00630414009810	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K984067	000

Storage Conditions

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