Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on Siemens analyzers

Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on Siemens analyzers
N FLC Control SL2 - 10482442

A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of kappa and/or lambda light chain immunoglobulins in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DFH

Device Name: Kappa, Antigen, Antiserum, Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

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: 866.5550

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00842768031465

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: 04056869221960

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