Reagent, Rickettsia Serological
Rickettsia serological reagents are in vitro diagnostic devices used to detect antibodies against Rickettsia species in patient serum, used in the diagnosis of rickettsial diseases such as Rocky Mountain spotted fever, typhus, and other tick-borne and insect-borne rickettsioses. They are classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LSQ, regulated under 21 CFR 866.3500, within the Microbiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LSQ
- Device Class
- FDA class 1
- Regulation Number
- 866.3500
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K971591 | INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) | Mar 13, 1998 | Substantially Equivalent | David C. Bishop, Ph.D. |
| K920569 | INDXTM DIP-S-TICKSTM | Feb 09, 1993 | Substantially Equivalent | Intercare Diagnostics, Inc. |
| K901597 | INDX DIP S TICKS | Dec 21, 1990 | Substantially Equivalent | Intercare Diagnostics, Inc. |
| K872129 | LATEX R. CONORII | Aug 19, 1987 | Substantially Equivalent | Health Research, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.