IMMUNOFLOW™ Mycoplasma pneumoniae IgM Test 7005

GUDID 00613745000060

ImmunoFLOW Mycoplasma pneumoniae IgM Test detects human IgM to the complement-fixing antigen and is intended as an aid in the diagnosis of infection.

Genbio

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

• Primary Device ID: 00613745000060
• NIH Device Record Key: 2909c9ea-2b65-4e53-82fb-18e07e7db815
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMUNOFLOW™ Mycoplasma pneumoniae IgM Test
• Version Model Number: 800-7005
• Catalog Number: 7005
• Company DUNS: 940425333
• Company Name: Genbio
• 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

Customer Support Contacts

• Phone: 858-592-9300
• Email: orders@genbio.com
• Phone: 858-592-9300
• Email: orders@genbio.com
• Phone: 858-592-9300
• Email: orders@genbio.com
• Phone: 858-592-9300
• Email: orders@genbio.com
• Phone: 858-592-9300
• Email: orders@genbio.com
• Phone: 858-592-9300
• Email: orders@genbio.com
• Phone: 858-592-9300
• Email: orders@genbio.com
• Phone: 858-592-9300
• Email: orders@genbio.com
• Phone: 858-592-9300
• Email: orders@genbio.com
• Phone: 858-592-9300
• Email: orders@genbio.com
• Phone: 858-592-9300
• Email: orders@genbio.com
• Phone: 858-592-9300
• Email: orders@genbio.com
• Phone: 858-592-9300
• Email: orders@genbio.com
• Phone: 858-592-9300
• Email: orders@genbio.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613745000060 [Primary]

FDA Product Code

• LJZ: Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-08
• Device Publish Date: 2025-08-31

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