IFA: Granulocyte Mosaic 13

Basic Information

• Brand Name: IFA: Granulocyte Mosaic 13
• Primary DI: 04049016072102
• Version / Model: FB 1201-2010-13
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• Labeler DUNS: 322209263
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-06
• Public Version: 1
• Public Version Date: 2019-06-14
• Public Version Status: New
• Public Device Record Key: e91d7dab-7abc-43b2-a89c-cf9cb2bb367d

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55066	Multiple anti-neutrophil cytoplasmic antibody (ANCA) 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 qualitative and/or quantitative detection of one or multiple anti-neutrophil cytoplasmic antibodies (ANCA) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049016072102	GS1

Premarket Submissions

Submission Number	Supplement Number
K051489	000

Storage Conditions

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