QMedix™ 3122-15

GUDID 00850054026439

QMedix™TSH ELISA This test is intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Diagnostic Automation, Inc.

Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00850054026439
• NIH Device Record Key: b952f0a6-fb08-4d92-b270-69f29ceb91ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QMedix™
• Version Model Number: DACD3122-15
• Catalog Number: 3122-15
• 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	00850054026439 [Primary]

FDA Product Code

• JLW: Radioimmunoassay, Thyroid-Stimulating Hormone

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: 2024-02-08
• Device Publish Date: 2024-01-31

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