Candida Spp., Direct Antigen, Id
The Candida Species Direct Antigen Identification device is an in vitro diagnostic reagent used to directly detect Candida antigen in clinical specimens through immunological methods, enabling rapid identification of Candida infections without requiring culture. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LRF, regulated under 21 CFR 866.3165, within the Microbiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LRF
- Device Class
- FDA class 2
- Regulation Number
- 866.3165
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K883118 | ON THE SPOT CANDIDASURE | Sep 30, 1988 | Substantially Equivalent | Medi-Tech, Inc. |
| K863499 | CANDIDATE(R) SUPER | Mar 19, 1987 | Substantially Equivalent | Mercia Diagnostics , Ltd. |
| K843286 | EI-CANDIDA ENZYME IMMUNOASSAY EI1001 | Oct 01, 1984 | Substantially Equivalent | Immuno-Mycologics, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.