Product Code: GQM
FDA class 2
21 CFR 866.3305
Antisera, Neutralization, Herpesvirus Hominis
Microbiology
The Antisera, Neutralization, Herpesvirus Hominis is a neutralization antiserum used in laboratory settings to identify and differentiate herpes simplex virus through virus-neutralization assays. FDA Class 2 status means it presents moderate risk and requires a 510(k) premarket notification before it can be marketed. The product code is GQM, regulated under 21 CFR 866.3305 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
9
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Basic Information
- Product Code
- GQM
- Device Class
- FDA class 2
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
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 |
|---|---|---|---|---|
| K875367 | COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV | Mar 28, 1988 | Substantially Equivalent | Enzo Biochem, Inc. |
| K810043 | GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I | May 15, 1981 | Substantially Equivalent | Vibac Corp. |
| K791397 | HERPES EIA TEST KIT | Sep 24, 1979 | Substantially Equivalent | Microbiological Assoc. |