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Pro-Trac II Tacrolimus ELISA Kit

FDA PMA

Class II (US FDA PMA)

PMA P970025

by Diasorin Inc.

Identity

Trade Name
PRO-TRAC II TACROLIMUS ELISA KIT FDA PMA
Generic Name
ENZYME IMMUNOASSAY, TRACROLIMUS FDA PMA

Identifiers

PMA Number
P970025 FDA PMA
FDA Product Code
MLM FDA PMA

Classification

Device Class
Class II FDA PMA
Legislation / Framework
21 CFR Part 862.1678 FDA PMA
Regulation Number
862.1678 FDA PMA
Advisory Committee
Clinical Toxicology FDA PMA
FDA Decision
APRL FDA PMA

The Pro-Trac II Tacrolimus ELISA Kit is an enzyme immunoassay designed for the quantitative determination of tacrolimus (Prograf, FK506) and its metabolites in human whole blood collected in EDTA or heparin. It functions as an in vitro diagnostic tool to aid in the therapeutic management of liver transplant patients undergoing tacrolimus therapy by providing measurable blood concentration data.

This kit is supplied as a single-use diagnostic reagent intended for use in clinical chemistry laboratories. It requires no special storage conditions beyond those specified in the accompanying instructions, though sterility and proper handling are critical to maintaining assay accuracy. The device is classified under FDA’s Class II regulatory category (MLM product code) and holds a Premarket Approval (PMA) designation (PMA Number: P970025), ensuring compliance with stringent performance and safety standards for in vitro diagnostics.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Diasorin Inc.
FDA Applicant
DiaSorin, Inc.

Sources (1)

  • FDA PMA P970025 24 fields · synced Sep 18, 2026