510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PTFClass II

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

21 CFR 866.3215 / Microbiology
FDA source (opens on fda.gov)

PTF is the FDA product code for Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission, a class II device type, regulated under 21 CFR 866.3215. FDA's definition for this code reads: "Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PTF
Device name
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
FDA definition
Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code PTF

By decision year
4 clearances under product code PTF with a decision year between 2017 and 2025, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PTF by decision year
YearClearances
20171
20191
20231
20251

Applicants with the most clearances

Product code PTF
Applicants holding the most 510(k) clearances under product code PTF
ApplicantClearances
Siemens Healthcare Diagnostics Inc.2
Diasys Diagnostic Systems GmbH1
Diazyme Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code