Igm (Mu Chain Specific), Antigen, Antiserum, Control
This is an immunological reagent kit for detecting IgM with specificity for the mu heavy chain, the immunoglobulin class characteristic of primary immune responses and important in evaluating early-phase infections. The kit includes antigen, antiserum, and control components for use in clinical immunology laboratories. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DAO, regulated under 21 CFR 866.5550, within the Immunology specialty.
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Basic Information
- Product Code
- DAO
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K040431 | ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 | Mar 10, 2004 | Substantially Equivalent | Roche Diagnostics Corp. |
| K982639 | SPIFE URINE IFE | Nov 04, 1998 | Substantially Equivalent | Helena Laboratories |
| K955908 | BOEHRINGER MANNHEIM IGM ASSAY | Feb 09, 1996 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K850586 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M | Mar 14, 1985 | Substantially Equivalent | Applications Lab |
| K841992 | MODIFICATION TO ACS CORONARY GUIDING | Jun 11, 1984 | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. |
| K812487 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM | Sep 23, 1981 | Substantially Equivalent | Dako Corp. |
| K800450 | GEMENI IGM ASSAY | Apr 24, 1980 | Substantially Equivalent | Electro-Nucleonics Laboratories, Inc. |
| K790705 | ANTISERUM TO HUMAN IGM | Apr 12, 1979 | Unknown | Kent Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.