- Physicians Office Resource

The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.
Access PCT - C53987

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of procalcitonin (PCT) 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: PTF

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

Device Class: 2

Physical State: In vitro diagnostic device

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

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Latex particle enhanced immunoturbidimetric method intended for the quantitative determination of PCT in serum, EDTA or lithium heparin plasma.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Detection and determination of procalcitonin (PCT) concentration in serum or plasma

Regulation Number: 866.3215

Third Party Flag: N

Medical Specialty: MI

Device Identifiers

Device Id: 15099590736002

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

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