ARCHITECT Galectin-3 Controls

ARCHITECT Galectin
ARCHITECT - 5P03-10

A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative detection of galectin-3 protein in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OSX

Device Name: Galectin-3 In Vitro Diagnostic Assay

Device Class: 2

Physical State: in vitro diagnostic reagent kit

Definition: Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: enzyme linked immunosorbent assay (ELISA)

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: in vitro diagnostic for use with serum and plasma

Regulation Number: 862.1117

Third Party Flag: N

Medical Specialty: CH

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: 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: 00380740096144

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