Ortho Toxoplasma-G Antibody Elisa Test
by Ortho Diagnostic Systems, Inc.
510(k) K883937
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883937 | Date7 Feb 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LGD
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3780
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Ortho Toxoplasma-G Antibody Elisa Test is an enzyme linked immunoabsorbent assay designed for the detection of Toxoplasma gondii antibodies. It functions as a diagnostic tool within the field of microbiology.
This device is identified by FDA 510(k) number K883937 and is regulated under 21 CFR 866.3780. It is manufactured by Ortho Diagnostic Systems, Inc. and has received FDA 510(k) clearance.
Other devices from Ortho Diagnostic Systems, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the purpose of the Ortho Toxoplasma-G Antibody ELISA Test?
This device is an enzyme linked immunoabsorbent assay designed to function as a diagnostic tool in the field of microbiology for the detection of Toxoplasma gondii antibodies.
What is the regulatory status of this test?
The Ortho Toxoplasma-G Antibody ELISA Test has received FDA 510(k) clearance under the number K883937 and is regulated under 21 CFR 866.3780.
Who is the manufacturer of this diagnostic assay?
This device is manufactured by Ortho Diagnostic Systems, Inc., located in Carpinteria, California.