Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]

GUDID 08305900070248

The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum. This assay is intended for in vitro diagnostic use.

BIOMERICA, INC.

Calcitonin IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 08305900070248
• NIH Device Record Key: 7aefee90-652d-48fe-b50e-3ae61b8ffd7d
• Commercial Distribution Discontinuation: 2020-07-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]
• Version Model Number: 7024
• Company DUNS: 067647321
• Company Name: BIOMERICA, 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: false
• 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: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08305900070248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982491

FDA Product Code

• JKR: Radioimmunoassay, Calcitonin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-09-02
• Device Publish Date: 2016-12-07

On-Brand Devices [Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]]

• 00083059070248: The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in h
• 08305900070248: The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in h