Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Device Code: 3533
Product Code(s):
OPL Definition: The Test Is A Multiplex Immunoassay Intended For The Qualitative Detection Of Specific Human IgG Antibodies To Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus (VZV) In Human Serum And/ Or Plasma. The Results Of This Assay Are Intended
Device Classification Information
| Device Type ID | 3533 |
| Device Name | Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus |
| Physical State | The Device Is A Fully Automated Instrument |
| Technical Method | Multiplex Flow Immunoassay (multiplexed Fluromagnetic Bead Assay) |
| Target Area | The Device Is An In-vitro Diagnostic Device; None Of The Body Parts Will Utilize The Device Or Is Intended To Be Affected By The Device |
| 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 | OPL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3533 |
| Device | Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus |
| Product Code | OPL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Rubella Virus Serological Reagents. |
| CFR Regulation Number | 866.3510 [🔎] |
| Recalls |
|---|
| Manufacturer | Recall Class | Date Posted |
| 1 | Cell Marque Corporation | II | Jun-01-2017 |
TPLC Last Update: 2019-04-02 20:31:52