Agglutinotest-Toxoplasmosis
by Volu Sol Medical Industries 510(k)
Active
510(k) K791456
Overview
This device is an antigen test for Toxoplasma gondii, classified under the microbiology specialty. It is designed to detect antibodies to Toxoplasma gondii using agglutination methodology.
The device is supplied as a reagent kit for in vitro diagnostic use. It received FDA 510(k) clearance (K791456) on September 24, 1979, and is classified as a Class II medical device under regulation 866.3780 with product code GMN.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK791456 | Date24 Sep 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GMN
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3780
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Volu Sol Medical Industries
Questions
What is the AGGLUTINOTEST-TOXOPLASMOSIS used for?
The AGGLUTINOTEST-TOXOPLASMOSIS is an antigen test designed to detect antibodies to Toxoplasma gondii using agglutination methodology, intended for in vitro diagnostic use in microbiology testing.
How is the AGGLUTINOTEST-TOXOPLASMOSIS supplied and is it sterile or single-use?
The device is supplied as a reagent kit for in vitro diagnostic use; the data does not specify sterility or single-use status, so users should consult the product labeling for handling and usage instructions.
What regulatory clearance does the AGGLUTINOTEST-TOXOPLASMOSIS have and what is its classification?
The AGGLUTINOTEST-TOXOPLASMOSIS received FDA 510(k) clearance (K791456) on September 24, 1979, and is classified as a Class II medical device under regulation 866.3780 with product code GMN.