Antiserum, Fluorescent, Rubeola
The Antiserum, Fluorescent, Rubeola is a fluorescent-labeled antiserum used in immunofluorescence assays to detect the rubeola (measles) virus in clinical specimens. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls and requiring no premarket submission. The product code is GRE, regulated under 21 CFR 866.3520 in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GRE
- Device Class
- FDA class 1
- Regulation Number
- 866.3520
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K884004 | RUBEOLA TEST | Dec 05, 1988 | Substantially Equivalent | Gull Laboratories, Inc. |
| K853067 | FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT | Oct 22, 1985 | Substantially Equivalent | Idt, A Division of Whittaker M.A. Bioproducts |
| K821249 | ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS | Jul 30, 1982 | Substantially Equivalent | Electro-Nucleonics Laboratories, Inc. |
| K770687 | MEASLESVIRUS FLOURE. CONJUGATED ANTISERU | Jun 14, 1977 | Substantially Equivalent | Microbiological Assoc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.