ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures. (UDI Z-2207-2015)
Manufactured by Siemens Healthcare Diagnostics, Inc
Device Regulatory Overview
The ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures. (Model/Catalog Number: Unspecified) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc. This product is indexed under FDA Product Code / Category Classification ***This field action applies to all in-date lots of reagents (Kit lots ending in 088, 089, 090, 091, 093 and 094) and all future lots until the issue is resolved and a follow-up communication is issued by Siemens.**** SMN 10317708 - 100 tests 43796099 May 25, 2015 43818088 May 25, 2015 44793088 May 25, 2015 45687089 June 22, 2015 46527089 June 22, 2015 48096089 June 22, 2015 49216090 August3, 2015 50779090 August3, 2015 52113091 September 14, 2015 53091093 October 19, 2015 54684093 October 19, 2015 SMN 10317709 -500 tests 43797088 May25, 2015 43819088 May25,2015 44098088 May25, 2015 44623088 May 25, 2015 45688089 June 22, 2015 46661089 June 22, 2015 48301090 August3, 2015 49869090 August 3, 2015 50884091 September 14, 2015 51471091 September 14, 2015 51798091 September 14, 2015 53092093 October 19,2015 53231093 October 19,2015 54742094 December 6, 2015 within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- N/A
- Device Name
- ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.
- Database Sync Date
- 2026-08-09 10:06:45
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.?
The registered manufacturer of record for ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures. is Siemens Healthcare Diagnostics, Inc.
What is the Primary UDI-DI identifier for ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-2207-2015.
What classification code is assigned to this device?
This device is registered under product classification code ***This field action applies to all in-date lots of reagents (Kit lots ending in 088, 089, 090, 091, 093 and 094) and all future lots until the issue is resolved and a follow-up communication is issued by Siemens.**** SMN 10317708 - 100 tests 43796099 May 25, 2015 43818088 May 25, 2015 44793088 May 25, 2015 45687089 June 22, 2015 46527089 June 22, 2015 48096089 June 22, 2015 49216090 August3, 2015 50779090 August3, 2015 52113091 September 14, 2015 53091093 October 19, 2015 54684093 October 19, 2015 SMN 10317709 -500 tests 43797088 May25, 2015 43819088 May25,2015 44098088 May25, 2015 44623088 May 25, 2015 45688089 June 22, 2015 46661089 June 22, 2015 48301090 August3, 2015 49869090 August 3, 2015 50884091 September 14, 2015 51471091 September 14, 2015 51798091 September 14, 2015 53092093 October 19,2015 53231093 October 19,2015 54742094 December 6, 2015.
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