Definition: The Qualitative Detection Of Measles Specific IgM Antibodies In Serum Or Plasma.
| Device Type ID | 3557 |
| Device Name | Enzyme Linked Immunoabsorbent Assay, Rubeola Igm |
| Physical State | IVD Reagent Kit |
| Technical Method | Antigens And Antisera Used For The Detection Of Measles Antibodies |
| Target Area | Not Applicable In Vitro Use |
| Regulation Description | Rubeola (measles) 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) Exempt |
| CFR Regulation Number | 866.3520 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PCL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3557 |
| Device | Enzyme Linked Immunoabsorbent Assay, Rubeola Igm |
| Product Code | PCL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Rubeola (measles) Virus Serological Reagents. |
| CFR Regulation Number | 866.3520 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
TRINITY BIOTECH, PLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | III | Sep-12-2016 |