Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- DEPLambda, Peroxidase, Antigen, Antiserum, Control2Product Code
- DEYIgm, Peroxidase, Antigen, Antiserum, Control2Product Code
- DFDKappa, Peroxidase, Antigen, Antiserum, Control2Product Code
- DGHIgd, Peroxidase, Antigen, Antiserum, Control2Product Code
- DAAIgg, Peroxidase, Antigen, Antiserum, Control2Product Code
- DGOIge, Peroxidase, Antigen, Antiserum, Control2Product Code
- DHFD/Km-1, Antigen, Antiserum, Control1Product Code
- LYECytokeratins2Product Code
- NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection2Product Code
- PFRSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection2Product Code
- PFSSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection2Product Code
- PKBAutosomal Recessive Carrier Screening Gene Mutation Detection System2Product Code
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
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Ige, Peroxidase, Antigen, Antiserum, Control
- Page Type
- Product Code
- Regulation Medical Specialty
- Immunology
- Review Panel
- Pathology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 866.5510
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 866.5510 Immunoglobulins A, G, M, D, and E immunological test system
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a) Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
(b) Classification. Class II (performance standards).