VIDAS ® B·R·A·H·M·S PCT™ (PCT) is an automated test for use on the VIDAS ® instruments for the determination of procalcitonin in human serum or plasma.

VIDAS ® B·R·A·H·M·S PCT™ (PCT) is an automated test for use on the VIDAS ® instruments for the determination of procalcitonin in human serum or plasma.
VIDAS® B·R·A·H·M·S PCT ™ - 30450-01

A collection of reagents and other associated materials intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen, using an enzyme immunoassay (EIA) method. Procalcitonin is typically used as a marker of bacterial sepsis or severe bacterial infection.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NTM

Device Name: Antigen, Inflammatory Response Marker, Sepsis

Device Class: 2

Physical State: N/A

Definition: An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.

Submission Type ID: 1

Review Panel: MI

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: 866.3210

Third Party Flag: N

Medical Specialty: MI

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

Device Id: 03573026223601

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