Radioimmunoassay, Immunoglobulins (D, E)
Radioimmunoassay for Immunoglobulins D and E is an immunology test system employing radioactive tracer competition to quantify IgD and IgE immunoglobulin levels in serum, used in the diagnosis of allergic disorders, parasitic infections, and immunodeficiency states. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JHR, regulated under 21 CFR 866.5510, within the Immunology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JHR
- Device Class
- FDA class 2
- Regulation Number
- 866.5510
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K061970 | ELECSYS IGE II IMMUNOASSAY | Aug 31, 2006 | Substantially Equivalent | Roche Diagnostics |
| K984326 | ELECYS IGE ASSAY | Feb 08, 1999 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K960067 | IMMILITE TOTAL IGE | Feb 14, 1996 | Substantially Equivalent | Diagnostic Products Corp. |
| K931703 | IMMULITE TOTAL IGE | Aug 16, 1993 | Substantially Equivalent | Diagnostic Products Corp. |
| K903000 | TURBO-RAST SPECIFIC IGE ASSAY | Jul 31, 1990 | Substantially Equivalent | Ventrex Laboratories, Inc. |
| K901859 | COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 | May 03, 1990 | Substantially Equivalent | Diagnostic Products Corp. |
| K882616 | ALTERNATE PROCEDURE, PHARMACIA IGE EIA | Aug 04, 1988 | Substantially Equivalent | Pharmacia, Inc. |
| K873077 | PHARMACIA IGE EIA | Oct 20, 1987 | Substantially Equivalent | Pharmacia, Inc. |
| K840103 | RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN | Feb 10, 1984 | Substantially Equivalent | Techniclone Intl. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.