ImmunoFA Toxoplasma IgM 1300

GUDID 00613745013008

The ImmunoFA Toxo IgM Test is an immunofluorescence test for the presumptive detection and titration of IgM antibodies to Toxoplasma gondii in human serum and is presumptive for the diagnosis of acute, recent, or reactivated T. gondii infection. It is intended that the ImmunoFA Toxo IgG Test be performed in conjunction with this assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.

Genbio

Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 00613745013008
• NIH Device Record Key: ea6cb8f7-5ae9-4ba3-9fe1-23273e1bb18f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmunoFA Toxoplasma IgM
• Version Model Number: 800-1300
• Catalog Number: 1300
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613745013008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K803134

FDA Product Code

• GLZ: Antigens, If, Toxoplasma Gondii

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by Genbio

• 00613745000046 - ImmunoDOT Leptospira IgM: 2018-07-06 The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptosp
• 00613745000152 - ImmunoDOT Leptospira IgM: 2018-07-06 The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptosp
• 00613745000169 - ImmunoDOT Leptospira IgM: 2018-07-06 The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptosp
• 00613745010052 - ImmunoFA 10x PBS: 2018-07-06 10-fold concentrate of 0.01M PBS
• 00613745010069 - ImmunoFA 10x PBS: 2018-07-06 10-fold concentrate of 0.01M PBS
• 00613745010250 - ImmunoFA Mounting Fluid: 2018-07-06 Mounting fluid for use with ImmunoFA kits.
• 00613745012001 - ImmunoFA Toxoplasma IgG: 2018-07-06 The ImmunoFA Toxo IgG Test is an immunofluorescence test for the detection and titration of IgG antibodies to Toxoplasma gondii
• 00613745012018 - ImmunoFA Toxoplasma Slides: 2018-07-06 Toxoplasma Slides for use with ImmunoFA Toxoplasma kits