Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- 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
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Plates And Equipment, Radial Immunodiffusion
- Page Type
- Product Code
- Regulation Medical Specialty
- Immunology
- Review Panel
- Immunology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 866.4800
- 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 § 866.4800 Radial immunodiffusion plate
§ 866.4800 Radial immunodiffusion plate.
(a) Identification. A radial immunodiffusion plate for clinical use is a device that consists of a plastic plate to which agar gel containing antiserum is added. In radial immunodiffusion, antigens migrate through gel which originally contains specific antibodies. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and 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 66 FR 38792, July 25, 2001]