Lyme ELISA (IgG/IgM)

Basic Information

• Brand Name: Lyme ELISA (IgG/IgM)
• Primary DI: 04049016114895
• Version / Model: EI 2132-9601-24 O
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• Labeler DUNS: 322209263
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3ba1d927-e145-47d2-94ce-f03c4ab35633

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
LSR	Reagent, Borrelia Serological Reagent	Microbiology	866.3830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50568	Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049016114895	GS1

Premarket Submissions

Submission Number	Supplement Number
K142038	000

Storage Conditions

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