Igm, Fitc, Antigen, Antiserum, Control
The IgM FITC Antigen, Antiserum, and Control is a fluorescein isothiocyanate (FITC)-conjugated immunological reagent used for fluorescent detection of IgM immunoglobulins in laboratory assays. It is classified as FDA Class 2, indicating moderate risk and a requirement for 510(k) premarket notification, and is regulated under 21 CFR 866.5550 within the Immunology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DFS
- Device Class
- FDA class 2
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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 |
|---|---|---|---|---|
| K831907 | RABBIT ANTISERUM TO HUMAN IGM | Jul 19, 1983 | Substantially Equivalent | Dako Corp. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.