IDG/Sanzay

Basic Information

• Brand Name: IDG/Sanzay
• Primary DI: 00850053916182
• Version / Model: 1
• Catalog Number: HC101
• Company Name: IDG/SANZAY Corporation
• Labeler DUNS: 948875013
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-12
• Public Version: 1
• Public Version Date: 2024-01-22
• Public Version Status: New
• Public Device Record Key: 4a2c0573-6afa-4d77-b8b8-0961a911a961

Device Description

The IDG PT-HS reagent is an in vitro diagnostic assay intended for use in performing the one stage prothrombin time (PT) test and assays which are based on a modified prothrombin time.

Device Characteristics

• Single Use: No
• 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
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	00850053916182	GS1

Premarket Submissions

Submission Number	Supplement Number
K020840	000

Storage Conditions

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