Tinaquant Hemoglobin A1c III

Basic Information

• Brand Name: Tinaquant Hemoglobin A1c III
• Primary DI: 04015630926275
• Version / Model: 5336163190
• Catalog Number: 5336163190
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0a8eaf15-7da3-4d49-bfd1-8e73d55135d3

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
LCP	ASSAY, GLYCOSYLATED HEMOGLOBIN	Hematology	864.7470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59090	Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c) 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	04015630926275	GS1

Premarket Submissions

Submission Number	Supplement Number
K102914	000

Storage Conditions

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