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.
| Device Type ID | 3582 |
| Device Name | Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm |
| Physical State | In-vitro Diagnostic Kit. |
| Technical Method | The Device Utilizes Multiplex Fluorescence Technology. |
| Target Area | Human Serum / Plasma |
| 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 | PUQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3582 |
| Device | Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm |
| Product Code | PUQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Rubella Virus Serological Reagents. |
| CFR Regulation Number | 866.3510 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
Bio-Rad Laboratories | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIO-RAD LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |