Antisera, Latex Agglutination, Cryptococcus Neoformans
The Latex Agglutination Antisera for Cryptococcus Neoformans is a microbiology reagent used to detect capsular antigens or antibodies associated with Cryptococcus neoformans, a pathogenic fungus responsible for cryptococcal meningitis and other serious infections. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GMD, regulated under 21 CFR 866.3165 in the Microbiology specialty.
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Basic Information
- Product Code
- GMD
- 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 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K112422 | CRAG LATERAL FLOW ASSAY (LFA) | Mar 28, 2012 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K102286 | CRAG LATERAL FLOW ASSAY (CRAG LFA) | Jul 20, 2011 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K930418 | CRYPTO-LEX SYSTEM | Feb 17, 1994 | Substantially Equivalent | Trinity Laboratories, Inc. |
| K933997 | PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY | Nov 22, 1993 | Substantially Equivalent | Alexon Biomedical, Inc. |
| K894845 | (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE | Sep 08, 1989 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K812188 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI | Aug 31, 1981 | Substantially Equivalent | American Scientific Products |
| K810510 | YA-CRYPTO ANTIBODY TUBE AGGLUTINATION | Mar 20, 1981 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K792693 | CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX | Jan 21, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K791382 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K780526 | CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM | Apr 28, 1978 | Substantially Equivalent | I M, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.