TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT

GUDID 08305900070316

The cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).

BIOMERICA, INC.

Troponin T/Troponin I IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 08305900070316
• NIH Device Record Key: 166313dd-d632-4561-8d26-60b0775d1309
• Commercial Distribution Discontinuation: 2020-07-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT
• Version Model Number: 7031
• 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	08305900070316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013062

FDA Product Code

• MMI: Immunoassay Method, Troponin Subunit

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: 2016-12-08

On-Brand Devices [TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT]

• 00083059070316: The cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human ser
• 08305900070316: The cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human ser