Anti-PLA2R IFA

Basic Information

• Brand Name: Anti-PLA2R IFA
• Primary DI: 04049016095781
• Version / Model: FA 1254-1005-50
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• Labeler DUNS: 322209263
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-10
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7e888142-6bca-45bc-9509-1b3e54b6fa82

Device Characteristics

• Single Use: Yes
• 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
PGV	Anti-Phospholipase A2 Receptor	Microbiology	866.5780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62337	Phospholipase A2 receptor (PLA2R) antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative detection of antibodies to the phospholipase A2 receptor (PLA2R) in a clinical specimen, using a fluorescent immunoassay method. It is used as an aid in the diagnosis of the kidney disease known as primary membranous glomerulonephritis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049016095781	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN140002	000

Storage Conditions

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