Antigen, Cf, Aspergillus Spp.
Antigen, CF, Aspergillus Spp. is a microbiological reagent containing Aspergillus species antigen used in complement fixation (CF) serological tests to detect antibodies against Aspergillus in patient serum, supporting the diagnosis of aspergillosis in immunocompromised individuals. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JWT, regulated under 21 CFR 866.3040, and falls within the Microbiology medical specialty.
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Basic Information
- Product Code
- JWT
- Device Class
- FDA class 1
- Regulation Number
- 866.3040
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K812740 | REAGENTS FOR SERODIAGNOSIS OF ASPERGILL | Oct 20, 1981 | Substantially Equivalent | Nolan Biological Laboratories, Inc. |
| K792700 | ASPERGILLUS SP, COMPLEMENT FIXATION | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K791387 | ASPERGILLUS MYCELIAL ANTIGEN #CF10024X | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K790672 | ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU | May 31, 1979 | Substantially Equivalent | Diagnostica, Inc. |
| K760830 | ASPERGILLUS MYCELIAL ANTIGEN | Nov 01, 1976 | Substantially Equivalent | I M, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.