Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
Device Code: 3529
Product Code(s):
OMI Definition: The Kit Is A Multiplex Immunoassay Intended For The Quantitative Detection Of IgG Antibodies To Toxoplasma Gondii (T. Gondii) And Rubella, And Qualitative Detection Of Cytomegalovirus (CMV) IgG In Human Serum And/ Or Plasma. Indicated As An Aid In Th
Device Classification Information
| Device Type ID | 3529 |
| Device Name | Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv |
| Physical State | The Device Is A Fully Automated Instrument. |
| Technical Method | The Device Utilizes Multiplex Immunofluorescence Technology To Assess The Presence Of IgG Antibodies For Each Of The Analytes In The Panel In A Single Sample By Binding To Antigen-coated Fluoromagnetic Beads With Unique Fluorescent Signatures. |
| Target Area | Assay |
| Regulation Description | Rubella Virus Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3510 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OMI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3529 |
| Device | Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv |
| Product Code | OMI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Rubella Virus Serological Reagents. |
| CFR Regulation Number | 866.3510 [🔎] |
| Device Problems |
|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
| Total Device Problems | 1 |
TPLC Last Update: 2019-04-02 20:31:47