Titin ELISA Analyzer IN015-E

GUDID 00816870024004

MONOBIND, INC.

Microplate reader IVD, automated/semi-automated

• Primary Device ID: 00816870024004
• NIH Device Record Key: c9a026df-40db-4b8b-a3a7-730444c83a4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titin ELISA Analyzer
• Version Model Number: IN015-E
• Catalog Number: IN015-E
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816870024004 [Primary]

FDA Product Code

• JJE: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

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: 2024-09-23
• Device Publish Date: 2024-09-13

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