IDG/Sanzay

Basic Information

• Brand Name: IDG/Sanzay
• Primary DI: 00850053916144
• Version / Model: 1
• Catalog Number: C391
• 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: 01aeb147-0e14-4327-bc41-48459849b2ad

Device Description

For the quantitative determination of total protein concentration in human serum.

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: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	862.1635	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53989	Total protein 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 total protein in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850053916144	GS1

Premarket Submissions

Submission Number	Supplement Number
K864743	000

Device Sizes

Type	Value	Unit	Text
Total Volume	100	Milliliter
Total Volume	120	Milliliter
Total Volume	1	Liter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius