Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI).
Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac
troponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay Systems to aid in the diagnosis
of myocardial infarction (MI).
Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac
troponin I (cTnI) levels in human serum and plasma using the DxI Access Immunoassay Analyzers to aid in the diagnosis
of myocardial infarction (MI).
Access hsTnI - B52669
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 15099590693183
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