Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
The Enzyme-Linked Immunosorbent Assay (ELISA) for Rubeola IgM is a microbiology in vitro diagnostic device used for the qualitative detection of measles-specific IgM antibodies in serum or plasma, supporting the diagnosis of active measles (rubeola) infection. It falls under the Microbiology medical specialty and is classified as a Class 1 device under regulation 866.3520, subject to general controls only, which may include GMP exemption considerations. Class 1 reflects the relatively lower risk of this type of serological assay. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PCL
- Device Class
- FDA class 1
- Regulation Number
- 866.3520
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
Definition
The qualitative detection of measles specific IgM antibodies in serum or plasma.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140455 | CAPTIA MEASLES IGM | May 22, 2014 | Substantially Equivalent | Trinity Biotech USA |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.