Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only

Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only
BioPlex 2200 - SW4.1_1

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antiphospholipid antibodies associated with antiphospholipid syndrome, in a clinical specimen, using a multiplex method.

No Data Available

• 1 Each

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MID

Device Name: System, Test, Anticardiolipin Immunological

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: 866.5660

Third Party Flag: Y

Medical Specialty: IM

Code: MSV

Device Name: System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

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: 866.5660

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00847865012997

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