- Physicians Office Resource

BioPlex 2200 ToRC IgM Reagent Pack
BioPlex 2200 - 12000670

Device Description

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

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

150 Tests

150 Tests

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LGD

Device Name: Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

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: 866.3780

Third Party Flag: Y

Medical Specialty: MI

Code: LKQ

Device Name: Antibody Igm,If, Cytomegalovirus Virus

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: 866.3175

Third Party Flag: Y

Medical Specialty: MI

Code: LFZ

Device Name: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

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: 866.3175

Third Party Flag: N

Medical Specialty: MI

Code: PUQ

Device Name: Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm

Device Class: 2

Physical State: In-vitro diagnostic kit.

Definition: The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device utilizes multiplex fluorescence technology.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human serum / plasma

Regulation Number: 866.3510

Third Party Flag: N

Medical Specialty: MI

Device Identifiers

Device Id: 03610520992715

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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