Slide Platelet Aggregation Test Reagent

Basic Information

• Brand Name: Slide Platelet Aggregation Test Reagent
• Primary DI: 00817869020014
• Version / Model: CR-121-1
• Catalog Number: CR-121-1
• Company Name: ANALYTICAL CONTROL SYSTEMS INC
• Labeler DUNS: 038232682
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-31
• Public Version: 1
• Public Version Date: 2019-03-04
• Public Version Status: New
• Public Device Record Key: 2798289e-a26b-4065-a2ce-17ec57a917b5

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
GFO	Activated Partial Thromboplastin	Hematology	864.7925	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
Primary	00817869020014	GS1
Package	10817869020011	GS1	6 Pack	6	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K921118	000