Procalcitonin (PCT) DM EXL LOCI BRAHMS - RGT

Procalcitonin (PCT) DM EXL LOCI BRAHMS
DM EXL LOCI BRAHMS PCT - 11354447

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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: 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: 00630414298214

Device Type: Unit of Use

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

Device Id: 00630414238692

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