Anti-Mycoplasma pneumoniae ELISA (IgM)

Basic Information

• Brand Name: Anti-Mycoplasma pneumoniae ELISA (IgM)
• Primary DI: 04049016027669
• Version / Model: EI 2202-9601 M
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• Labeler DUNS: 322209263
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2019-03-01
• Public Version Status: Update
• Public Device Record Key: ca4cbfd9-818d-451e-a545-72f04dae695e
• Distribution End Date: 2019-03-01

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: Yes
• 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
LJZ	Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.	Microbiology	866.3375	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51202	Mycoplasma pneumoniae immunoglobulin M (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 M (IgM) antibodies to Mycoplasma pneumoniae bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049016027669	GS1

Storage Conditions

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