Immunoglobulin M 360 Tests

Immunoglobulin M 360 Tests
Alinity - 09P6324

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin M (IgM total) in a clinical specimen, using a nephelometry/turbidimetry method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DFT

Device Name: Igm, 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: 00380740169916

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