Antiserum, Fluorescent, Mumps Virus
The Antiserum, Fluorescent, Mumps Virus is a fluorescent-labeled antiserum used in immunofluorescence assays to identify mumps virus in clinical laboratory specimens. It is an FDA Class 1 device, presenting the lowest risk and requiring only general controls with no premarket notification. The product code is GRA, regulated under 21 CFR 866.3380 in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GRA
- Device Class
- FDA class 1
- Regulation Number
- 866.3380
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K894624 | MUMPS VIRUS | Oct 16, 1989 | Substantially Equivalent | Bion Ent., Ltd. |
| K822826 | ANTIBODY TO MUMPS VIRUS IFA TEST | Dec 03, 1982 | Substantially Equivalent | Electro-Nucleonics Laboratories, Inc. |
| K770216 | VIRAL ANTISERA, FLUORESCEIN LABELED | Mar 01, 1977 | Substantially Equivalent | Flow Laboratories, Inc. |
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.