PL Chip

Basic Information

• Brand Name: PL Chip
• Primary DI: 04589448510082
• Version / Model: N/A
• Catalog Number: 18002
• Company Name: ZACROS CORPORATION
• Labeler DUNS: 690584370
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2024-12-12
• Public Version: 1
• Public Version Date: 2024-12-20
• Public Version Status: New
• Public Device Record Key: c89d9efa-201a-4d0a-acc4-4543b8f3e8d1

Device Description

Flow chamber microchip used to measure platelet thrombus formation (primary hemostatic function)

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
JOZ	System, Automated Platelet Aggregation	Hematology	864.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56092	Platelet aggregation study IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, which may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	14589448510089	GS1
Primary	04589448510082	GS1

Premarket Submissions

Submission Number	Supplement Number
K191364	000