Plates And Equipment, Radial Immunodiffusion
Plates and Equipment, Radial Immunodiffusion are immunological laboratory devices used for radial immunodiffusion (Mancini technique), in which an antigen diffuses radially through antibody-containing agar to produce a precipitin ring, allowing quantification of specific serum proteins such as immunoglobulins and complement components. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JZQ, regulated under 21 CFR 866.4800, and falls within the Immunology medical specialty.
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Basic Information
- Product Code
- JZQ
- Device Class
- FDA class 1
- Regulation Number
- 866.4800
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K881174 | RID PLATE READER | Jun 08, 1988 | Substantially Equivalent | The Binding Site, Ltd. |
| K881675 | IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS | Apr 21, 1988 | Substantially Equivalent | Dynatech Laboratories, Inc. |
| K831811 | REVOLUTION RADIAL IMMUNODIFFUSION PLATE | Jul 28, 1983 | Substantially Equivalent | Calbiochem-Behring Corp. |
| K792699 | OUCHTERLONY AGAR PLATES | Jan 24, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K790646 | HELENA QUIPLATE SYSTEM | May 23, 1979 | Substantially Equivalent | Helena Laboratories |
| K770548 | IMMUNOPLATE III RADIO IMMUNODIFFUSION | Apr 15, 1977 | Substantially Equivalent | Hyland Therapeutic Div., Travenol Laboratories |
| K761311 | ACCRAASSAY RID KITS | Dec 30, 1976 | Substantially Equivalent | Miles Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.