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
- 8.00
- 2.00
Device Sizes
- 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 IdentifiersDevice 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