Phosphoplastin RL

Basic Information

• Brand Name: Phosphoplastin RL
• Primary DI: 10859394006030
• Version / Model: 11-310
• Catalog Number: 11-310
• Company Name: R 2 DIAGNOSTICS, INC.
• Labeler DUNS: 956610125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-11-15
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 34333a9d-95bc-4750-82b4-9fbc5ee2fe4c

Device Description

PT reagent 10 x 10 ml

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: 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
GJS	Test, Time, Prothrombin	Hematology	864.7750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55986	Prothrombin time (PT) 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 quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10859394006030	GS1
Unit of Use	00859394006033	GS1

Premarket Submissions

Submission Number	Supplement Number
K040296	000