- Physicians Office Resource

U.S. IFU, Manual & CDs, BioPlex 2200, MMRV IgG IFU, SW4_v2
BioPlex 2200 - SW 4_2

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to varicella-zoster virus (VZV) in a clinical specimen, using a fluorescent immunoassay method.

Environmental Conditions

No Data Available

Device Sizes

1 Each

1 Each

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LJY

Device Name: Enzyme Linked Immunoabsorbent Assay, Mumps Virus

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 866.3380

Third Party Flag: N

Medical Specialty: MI

Code: LJB

Device Name: Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

Device Class: 1

Physical State: IVD reagent kit

Definition: The qualitative detection of measles specific IgG antibodies in serum or plasma.

Submission Type ID: 4

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: antigens and antisera used for the detection of measles antibodies

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not applicable in vitro use

Regulation Number: 866.3520

Third Party Flag: N

Medical Specialty: MI

Code: LFY

Device Name: Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

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: 866.3900

Third Party Flag: Y

Medical Specialty: MI

Code: OPL

Device Name: Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

Device Class: 2

Physical State: The device is a fully automated instrument

Definition: The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay are intended to be used as an aid in the assessment of a patient¿s serological status to measles virus, mumps virus, Rubella and VZV. The test is not intended for use in screening blood or plasma donors.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Multiplex flow immunoassay (multiplexed fluromagnetic bead assay)

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: The device is an in-vitro diagnostic device; none of the body parts will utilize the device or is intended to be affected by the device

Regulation Number: 866.3510

Third Party Flag: Y

Medical Specialty: MI

Device Identifiers

Device Id: 00847865002189

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

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