Monobind AccuBind Anti-TPO ELISA Kit - 96 Wells 1125-300A

GUDID 00816870020396

MONOBIND, INC.

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• Primary Device ID: 00816870020396
• NIH Device Record Key: b3c77505-1018-43eb-8eb9-62139e5dd5f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monobind AccuBind Anti-TPO ELISA Kit - 96 Wells
• Version Model Number: 1125-300
• Catalog Number: 1125-300A
• Company DUNS: 083155515
• Company Name: MONOBIND, 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: 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: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch

Operating and Storage Conditions

• 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
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816870020396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971834

FDA Product Code

• JNL: IMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY

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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