The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the highly sensitive quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.

The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the highly sensitive quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.
Access AccuTnI+3 - A98143

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen, using a chemiluminescent immunoassay method.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MMI

Device Name: Immunoassay Method, Troponin Subunit

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1215

Third Party Flag: N

Medical Specialty: CH

Device Id: 15099590209322

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A