Antigen, Cf, B. Dermatitidis
Antigen, CF, B. Dermatitidis is a microbiological reagent containing Blastomyces dermatitidis antigen used in complement fixation (CF) serological assays to detect antibodies to the causative agent of blastomycosis, a systemic fungal infection primarily affecting the lungs. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) or equivalent premarket review. The product code is JWW, regulated under 21 CFR 866.3060, and falls within the Microbiology medical specialty.
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Basic Information
- Product Code
- JWW
- Device Class
- FDA class 2
- Regulation Number
- 866.3060
- 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 |
|---|---|---|---|---|
| K802128 | IMMUNODIFFUSSION REAGENTS/SEROLOGICAL | Sep 26, 1980 | Substantially Equivalent | Nolan Biological Laboratories, Inc. |
| K792683 | BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION | Jan 23, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792680 | BLASTOMYCES DERMATITIDIS, ANTIGEN | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |