QuanTtest Human Protein Standards Set

Basic Information

• Brand Name: QuanTtest Human Protein Standards Set
• Primary DI: 00896863002356
• Version / Model: 3410-02
• Catalog Number: 3410-02
• Company Name: QUANTIMETRIX CORPORATION
• Labeler DUNS: 010717890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-10
• Public Version: 1
• Public Version Date: 2021-09-20
• Public Version Status: New
• Public Device Record Key: 01ef97d1-0daa-4369-aa76-dbd338a5ddf3

Device Description

QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red (Pyrogallol Red method) Total Protein Assay System. The standards are used to establish curves and to calibrate manual and automated methods for cerebrospinal fluid and urine total protein assays. Four protein standard concentrations are available: 25, 50, 100, and 200 mg/dl.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	862.1635	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53985	Total protein IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of total protein in a clinical specimen, using an enzyme spectrophotometry method.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00896863002356	GS1
Previous	M0513410021	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K853932	000

Storage Conditions

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