Antiserum, Positive Control, Aspergillus Spp.
Antiserum, Positive Control, Aspergillus Spp. is a laboratory reagent used as a positive control in immunological and microbiological tests for the detection of Aspergillus species, ensuring the accuracy and validity of diagnostic assays for fungal infections. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KFG, regulated under 21 CFR 866.3040, within the Microbiology medical specialty.
Research product code KFG in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- KFG
- 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 |
|---|---|---|---|---|
| K904499 | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) | Jul 01, 1991 | Substantially Equivalent | Ackrad Laboratories |
| K792698 | ASPERGILLUS SP, ANTISERUM, POSITIVE | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792686 | ASPERGILLUS SP, ANTISERUM POSITIVE | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K791386 | ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K760835 | ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) | Nov 01, 1976 | Substantially Equivalent | I M, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.