ImmunoCard Mycoplasma

Basic Information

• Brand Name: ImmunoCard Mycoplasma
• Primary DI: 00840733101762
• Version / Model: 709030
• Catalog Number: 709030
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Labeler DUNS: 092815364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-11
• Public Version: 2
• Public Version Date: 2023-09-26
• Public Version Status: Update
• Public Device Record Key: fcc81883-81dd-4a27-8235-e6800af3ea3a

Device Description

The ImmunoCard Mycoplasma enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgM to Mycoplasma pneumoniae in human serum. Test results are intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
LJZ	Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.	Microbiology	866.3375	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65851	Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of immunoglobulin M (IgM) antibodies to Mycoplasma pneumoniae bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840733101762	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K934550	000

Storage Conditions

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