The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 Reagent for the highly sensitive quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 System to aid in the diagnosis of myocardial infarction.
Access AccuTnI+3 Calibrators - A98144
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: JIT
Device Name: Calibrator, Secondary
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: 862.1150
Third Party Flag: N
Medical Specialty: CH
Device Identifiers
Device Id: 15099590209339
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
