LSQ · Reagent, Rickettsia Serological
Microbiology · 21 CFR 866.3500 · Class 1
Overview
| Product Code | LSQ |
|---|---|
| Device Name | Reagent, Rickettsia Serological |
| Regulation | 21 CFR 866.3500 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genus Rickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971591 | INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) | David C. Bishop, Ph.D. | Mar 13, 1998 | SESE |
| K920569 | INDXTM DIP-S-TICKSTM | Intercare Diagnostics, Inc. | Feb 9, 1993 | SESE |
| K901597 | INDX DIP S TICKS | Intercare Diagnostics, Inc. | Dec 21, 1990 | SESE |
| K872129 | LATEX R. CONORII | Health Research, Inc. | Aug 19, 1987 | SESE |
Top Applicants
- Intercare Diagnostics, Inc. — 2 clearances
- David C. Bishop, Ph.D. — 1 clearance
- Health Research, Inc. — 1 clearance
