ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST 3130

GUDID 00613745031309

ImmunoWELL Mycoplasma Pneumoniae Antibody (IgM) Test is a qualitative enzyme immunoassay (EIA) for the detection of specific IgM antibodies to M. pneumoniae in serum and is an aid in the diagnosis of M. pneumoniae infection.

Genbio

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

• Primary Device ID: 00613745031309
• NIH Device Record Key: ba0eaddc-d58e-48f9-a8a6-2fc24ce7ab0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST
• Version Model Number: 800-3130
• Catalog Number: 3130
• 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	00613745031309 [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: 2025-08-29

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