ELISA M. pneumoniae IgM Smart Kit Test System SM3Z17601M

GUDID 00845533000949

The ZEUS ELISA Mycoplasma pneumoniae IgM Test System provides a means for the qualitative detection of IgM antibodies to Mycoplasma pneumoniae in human sera. When performed according to these instructions, the results of this test may aid in the diagnosis of M. pneumoniae infections in the adult population. This assay is for In Vitro diagnostic use only.

ZEUS SCIENTIFIC, INC.

Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845533000949
• NIH Device Record Key: 89c6612b-c7b6-47bb-b8b6-c79806f4c7b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELISA M. pneumoniae IgM Smart Kit Test System
• Version Model Number: SM3Z17601M
• Catalog Number: SM3Z17601M
• Company DUNS: 080953946
• Company Name: ZEUS SCIENTIFIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533000949 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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