Antigen, Id, Candida Albicans
The Candida albicans ID antigen is a microbiological reagent used to identify Candida albicans strains by detecting specific surface antigens, supporting the laboratory diagnosis of candidal infections in clinical specimens. The device is FDA Class 2, indicating moderate risk, and does not require a 510(k) submission in this case as it falls under a premarket approval exemption for certain in vitro diagnostic devices. It carries product code LHK and is regulated under 21 CFR 866.3165 within the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LHK
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K893753 | DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST | Oct 16, 1989 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K823016 | CANDIDA DETECTION SYSTEM | Dec 28, 1982 | Substantially Equivalent | Ramco Laboratories, Inc. |
| K812741 | REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS | Oct 23, 1981 | Substantially Equivalent | Nolan Biological Laboratories, Inc. |
| K812186 | CANDIDA IMMUNODIFFUSION SYSTEM | Aug 25, 1981 | Substantially Equivalent | American Scientific Products |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.