Total Protein Urine/CSF Gen.3

Basic Information

• Brand Name: Total Protein Urine/CSF Gen.3
• Primary DI: 07613336121535
• Version / Model: 08058679190
• Catalog Number: 08058679190
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-05
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: 02fa08d4-50c6-4d3d-b502-e9fa9d26fad6

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
JGQ	TURBIDIMETRIC, TOTAL PROTEIN	Clinical Chemistry	862.1635	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53986	Total protein IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total protein in a clinical specimen, using a nephelometry/turbidimetry method. It is typically used to aid in the diagnosis of various conditions [e.g., liver, kidney, central nervous system (CNS) disorders.]	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613336121535	GS1

Premarket Submissions

Submission Number	Supplement Number
K141925	000

Storage Conditions

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