Alinity i BRAHMS PCT Reagent Kit 200 Tests

Alinity i BRAHMS PCT Reagent Kit 200 Tests
Alinity - 01R1821

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PMT

Device Name: Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Device Class: 2

Physical State: In vitro diagnostic device

Definition: An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Immunoassay, ELISA

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Detection and determination the concentration of PCT (procalcitonin) in human serum and EDTA or heparin plasma specimens.

Regulation Number: 866.3215

Third Party Flag: N

Medical Specialty: MI

Code: PRI

Device Name: Procalcitonin Assay

Device Class: 2

Physical State: In vitro diagnostic device

Definition: To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Immunoassay, ELISA

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human serum and EDTA or heparin plasma specimens.

Regulation Number: 866.3215

Third Party Flag: N

Medical Specialty: MI

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 Id: 00380740153953

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