IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern

Basic Information

• Brand Name: IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
• Primary DI: 04049016137894
• Version / Model: FC 1572-12010-1
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• Labeler DUNS: 322209263
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-11
• Public Version: 1
• Public Version Date: 2024-09-19
• Public Version Status: New
• Public Device Record Key: 6191e87b-0363-4fba-9277-90d4efd33d89

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
KTL	Anti-Dna Indirect Immunofluorescent Solid Phase	Immunology	866.5100	2
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	866.4750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54901	Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to double stranded DNA (anti-dsDNA) in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049016137894	GS1

Premarket Submissions

Submission Number	Supplement Number
K172252	000

Storage Conditions

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