Prospec T/Giardia Rapid Assay
by Alexon, Inc.
510(k) K911337
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911337 | Date27 Sep 1991 | 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- Withdrawn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
- MHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3220
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Prospect T/Giardia Rapid Assay is a microbiology device used for the detection of Giardia spp. It is a rapid assay designed to identify Giardia antigen in human fecal specimens.
This device is supplied as a test kit for use in clinical laboratory settings. It has received FDA 510(k) clearance under product code MHI and regulation number 866.3220, with the original clearance granted on September 27, 1991 (K911337). The assay is intended for qualitative detection and is used with fresh or preserved human fecal samples.
Other devices from Alexon, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the PROSPEC T/Giardia Rapid Assay used for?
The PROSPEC T/Giardia Rapid Assay is a microbiology device used for the qualitative detection of Giardia antigen in human fecal specimens. It is designed for use in clinical laboratory settings to help identify Giardia infections.
How is the PROSPEC T/Giardia Rapid Assay supplied?
The device is supplied as a test kit specifically designed for clinical laboratory use. It includes all necessary components for performing the qualitative detection of Giardia antigen in fresh or preserved human fecal samples.
What is the regulatory status of the PROSPEC T/Giardia Rapid Assay?
The PROSPEC T/Giardia Rapid Assay has received FDA 510(k) clearance under product code MHI and regulation number 866.3220. The original clearance was granted on September 27, 1991, with clearance number K911337.
What types of samples can be tested with the PROSPEC T/Giardia Rapid Assay?
The assay is intended for use with fresh or preserved human fecal specimens. It is designed specifically for qualitative detection of Giardia antigen in these sample types in clinical laboratory settings.