CHRONO-LOG

Basic Information

• Brand Name: CHRONO-LOG
• Primary DI: 00811476011670
• Version / Model: vW CoFactor Opti8 Software
• Company Name: CHRONO-LOG CORP
• Labeler DUNS: 002353696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-21
• Public Version: 1
• Public Version Date: 2023-06-29
• Public Version Status: New
• Public Device Record Key: 96b3d384-e967-43ad-bccb-9c218679bf9e

Device Description

vW CoFactor Opti8 Software

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JBX	Aggregrometer, Platelet	Hematology	864.6675	2
JOZ	System, Automated Platelet Aggregation	Hematology	864.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56699	Platelet aggregation analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of platelet function in a clinical specimen, by inducing platelet aggregation through the addition of platelet aggregating agents. The instrument may incorporate various technologies including electrical impedance, photometry, turbidimetry and/or luminescence together with sample processing, data processing and/or data display software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811476011670	GS1

Premarket Submissions

Submission Number	Supplement Number
K940792	000