WIESLAB antiGBM, ANCA Screen kit

Basic Information

• Brand Name: WIESLAB antiGBM, ANCA Screen kit
• Primary DI: 07340058410707
• Version / Model: GCP100
• Catalog Number: GCP100
• Company Name: Euro-Diagnostica AB
• Labeler DUNS: 559894501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-12
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a4f5ac4e-00a5-44c6-a244-c325364a2647

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
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54854	Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with vasculitis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at the glomerular basement membrane (GBM), anti-neutrophil cytoplamic antibodies to myeloperoxidase (ANCA MPO) and/or anti-neutrophil cytoplamic antibodies to proteinase-3 (PR3).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07340058410707	GS1

Premarket Submissions

Submission Number	Supplement Number
K981750	000