U.S. IFU, Manual & CDs, BioPlex 2200 Syphilis Total & RPR SW4.3

U.S. IFU, Manual & CDs, BioPlex 2200 Syphilis Total & RPR SW4.3
BioPlex 2200 - 4.3

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen.

No Data Available

• 1 Each

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GMQ

Device Name: Antigens, Nontreponemal, All

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: MI

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: 866.3820

Third Party Flag: Y

Medical Specialty: MI

Code: LIP

Device Name: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: MI

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: 866.3830

Third Party Flag: N

Medical Specialty: MI

Device Id: 03610520992692

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