Monobind Qsure Anti-Tg & Anti-TPO Control Set AIT-101

GUDID 00816870020174

MONOBIND, INC.

Thyroglobulin/Thyroid peroxidase antibody (anti-TPO/Microsomal antibody) IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid autoantibody IVD, control Multiple thyroid autoantibody IVD, control Multiple thyroid autoantibody IVD, control Multiple thyroid autoantibody IVD, control Multiple thyroid autoantibody IVD, control Multiple thyroid autoantibody IVD, control Multiple thyroid autoantibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control Multiple thyroid antibody IVD, control

• Primary Device ID: 00816870020174
• NIH Device Record Key: 13219f31-007f-4d46-b7c8-ee12729f0e2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monobind Qsure Anti-Tg & Anti-TPO Control Set
• Version Model Number: AIT-101
• Catalog Number: AIT-101
• Company DUNS: 083155515
• Company Name: MONOBIND, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com

Device Dimensions

• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch
• Width: 2 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816870020174 [Primary]

FDA Product Code

• JJY: Multi-analyte controls, all kinds (assayed)

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: 2019-03-11
• Device Publish Date: 2019-02-11

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