Product Code: GMN
FDA class 2
21 CFR 866.3780
Antigens, Cf, Toxoplasma Gondii
Microbiology
The Toxoplasma Gondii CF (Complement Fixation) Antigens are diagnostic reagents used in complement fixation serological tests to detect antibodies against Toxoplasma gondii, the parasite responsible for toxoplasmosis. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GMN, regulated under 21 CFR 866.3780 in the Microbiology specialty. This device is eligible for third-party 510(k) review.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
10
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Basic Information
- Product Code
- GMN
- Device Class
- FDA class 2
- Regulation Number
- 866.3780
- 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 |
|---|---|---|---|---|
| K894261 | TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN | Oct 16, 1989 | Substantially Equivalent | Microbix Biosystems, Inc. |
| K864981 | TOXOPLASMA GONDII | Oct 30, 1987 | Substantially Equivalent | Virion (U.S.), Inc. |
| K791456 | AGGLUTINOTEST-TOXOPLASMOSIS | Sep 24, 1979 | Substantially Equivalent | Volu Sol Medical Industries |