Direct Agglutination Test, Toxoplasma Gondii
Direct Agglutination Test, Toxoplasma Gondii is a serological diagnostic test that uses direct agglutination to detect antibodies against Toxoplasma gondii, the protozoan parasite that causes toxoplasmosis, a disease of particular concern in immunocompromised patients and during pregnancy. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LLA, regulated under 21 CFR 866.3780, within the Microbiology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- LLA
- Device Class
- FDA class 2
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
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 |
|---|---|---|---|---|
| K913467 | TOXOGEN | Jan 11, 1993 | Substantially Equivalent | Biokit USA, Inc. |
| K890048 | QUIK-DOT TOXOPLASMOSIS | Jun 09, 1989 | Substantially Equivalent | Ampcor, Inc. |
| K850768 | TOXOSCAN CARD TEST KIT | May 20, 1985 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K831930 | TOXO-SCREEN DA TEST | Sep 26, 1983 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.