Tina-quant IgG Gen.2

Basic Information

• Brand Name: Tina-quant IgG Gen.2
• Primary DI: 07613336121320
• Version / Model: 08057915190
• Catalog Number: 08057915190
• 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: 1
• Public Version Date: 2020-03-13
• Public Version Status: New
• Public Device Record Key: ca88961d-8027-419a-9c41-14420da9af80

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
DEW	IGG, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53785	Total immunoglobulin G (IgG total) 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 immunoglobulin G (IgG total) in a clinical specimen, using a nephelometry/turbidimetry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613336121320	GS1

Premarket Submissions

Submission Number	Supplement Number
K050113	000

Storage Conditions

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