The BN II is a system for the quantitative determination of proteins in serum, plasma, urine and CSF

The BN II is a system for the quantitative determination of proteins in serum, plasma, urine and CSF
BN II System - 11254820

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen using an immunological method which utilizes a nephelometric detection system to determine the rate and/or quantity of particle agglutination occurring through the formation of immune complexes, together with sample processing, data processing and/or data display software.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DEW

Device Name: Igg, 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: 866.5510

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00630414002903

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