ARCHITECT B.R.A.H.M.S PCT Calibrators

ARCHITECT B.R.A.H.M.S PCT Calibrators
ARCHITECT - 06P2201

A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JJX

Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

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: 862.1660

Third Party Flag: N

Medical Specialty: CH

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

Code: JIT

Device Name: Calibrator, Secondary

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

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: 862.1150

Third Party Flag: N

Medical Specialty: CH

Device Id: 00380740138905

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