Product Code: GRC
FDA class 1
21 CFR 866.3380
Antigen, Cf (Including Cf Control), Mumps Virus
Microbiology
The Antigen, CF (Including CF Control), Mumps Virus is a complement fixation antigen with controls used in clinical microbiology laboratories to measure antibody titers against the mumps virus. As an FDA Class 1 device, it is subject only to general controls and requires no premarket clearance. Regulated under 21 CFR 866.3380 with product code GRC in the Microbiology specialty. No special flags apply to this device.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
10
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Basic Information
- Product Code
- GRC
- Device Class
- FDA class 1
- Regulation Number
- 866.3380
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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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 |
|---|---|---|---|---|
| K905306 | MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN | Jun 17, 1991 | Substantially Equivalent | Virion (U.S.), Inc. |
| K832873 | MUMPS COMPLEMENT FIXATION & HEMAGGLU | Dec 27, 1983 | Substantially Equivalent | Hazleton Dutchland, Inc. |
| K802933 | MUMPS S & V ANTIGENS & CONTROLS | Dec 31, 1980 | Substantially Equivalent | Orion Diagnostica, Inc. |