QMedix™ 1101-1

GUDID 00850054026002

QMedix™Toxoplasma Gondii IgG ELISA Kit This test is intended for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen, using an enzyme immunoassay (EIA) method.

Diagnostic Automation, Inc.

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• Primary Device ID: 00850054026002
• NIH Device Record Key: 4e3aa194-013f-406d-9a89-6b1b5fb4d316
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QMedix™
• Version Model Number: DACD1101-1
• Catalog Number: 1101-1
• Company DUNS: 878252071
• Company Name: Diagnostic Automation, 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.com
• Phone: 8185913030
• Email: Onestep@rapidtest.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
• 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
• 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	00850054026002 [Primary]

FDA Product Code

• LGD: Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

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: 2024-02-12
• Device Publish Date: 2024-02-02

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