Antisera, If, Toxoplasma Gondii
Antisera, If, Toxoplasma Gondii is an immunofluorescence (IF) antiserum used in laboratory diagnostics to detect Toxoplasma gondii, the parasite responsible for toxoplasmosis, in patient specimens. It is classified as FDA Class 2, meaning it poses moderate risk and requires 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is LJK, regulated under 21 CFR 866.3780, and falls within the Microbiology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- LJK
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K974261 | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL | Dec 11, 1997 | Substantially Equivalent | Boston Biomedica, Inc. |
| K911771 | ARD(TM) ANTIMICROBIAL REMOVAL DEVICE | Jul 01, 1991 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K861122 | THE GOLDEN QUAD TEST (TOXO) | Feb 02, 1987 | Substantially Equivalent | Microbiological Research Corp. |
| K861460 | SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 | May 02, 1986 | Substantially Equivalent | Widran Urological Group, Ltd. |
| K832069 | TOXO IPA KIT IAN INDIRECT FLUORESCENT | Sep 26, 1983 | Substantially Equivalent | Bionetic Laboratory Products |
| K822605 | TOXOPLASMA GONDII ANTIBODY IGG | Oct 27, 1982 | Substantially Equivalent | Immulok, Inc. |
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.