VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers

VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers
VITROS - 6905561

A material which is used to verify the performance of 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: 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

Device Id: 10758750032945

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

Device Id: 20758750032942

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10758750032945

Package Quantity: 30

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case