Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
Device Code: 3534
Product Code(s):
OPM Definition: The Test Is A Multiplex Immunoassay Intended For The Qualitative Detection Of Specific Human IgG Antibodies To Toxoplasma Gondii (T.gondii), Rubella, Cytomegalovirus (CMV) And Herpes Simplex Virus 1 & 2 (HSV 1 And HSV 2) In Human Serum. The Results O
Device Classification Information
| Device Type ID | 3534 |
| Device Name | Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 |
| Physical State | Assay |
| Technical Method | Multiplex Flow Immunoassay (multiplexed Fluromagnetic Bead Assay) |
| Target Area | None |
| 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 | OPM |
| 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 | 3534 |
| Device | Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 |
| Product Code | OPM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Rubella Virus Serological Reagents. |
| CFR Regulation Number | 866.3510 [🔎] |
TPLC Last Update: 2019-04-02 20:31:53