Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- JZSElectrophoresis Instrumentation1Product Code
- JZTFluorometer1Product Code
- JZWNephelometer1Product Code
- DHLProtein, Complement, Antigen, Antiserum, Control1Product Code
- JZPPlates, Ouchterlony Agar1Product Code
- JZQPlates And Equipment, Radial Immunodiffusion1Product Code
- JZRSupport Gels1Product Code
- JZXEquipment, Rocket Immunoelectrophoresis1Product Code
- KTQReagent, Complement1Product Code
- PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use2Product Code
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
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Plates, Ouchterlony Agar
- Page Type
- Product Code
- Regulation Medical Specialty
- Immunology
- Review Panel
- Immunology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 866.4600
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 866.4600 Ouchterlony agar plate
§ 866.4600 Ouchterlony agar plate.
(a) Identification. An ouchterlony agar plate for clinical use is a device containing an agar gel used to examine antigen-antibody reactions. In immunodiffusion, antibodies and antigens migrate toward each other through gel which originally contained neither of these reagents. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and is immobilized.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 FR 38792, July 25, 2001]