Pneumocystis Carinii
The Pneumocystis Carinii detection device (product code LYF) is a microbiology diagnostic reagent used to detect Pneumocystis carinii (now classified as Pneumocystis jirovecii) in patient specimens, aiding in the diagnosis of Pneumocystis pneumonia (PCP), a serious opportunistic infection in immunocompromised patients. Regulated under 21 CFR 866.3780 and classified as a Class 2 device, it requires a 510(k) premarket notification and is eligible for third-party review. The device falls under the Microbiology specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- LYF
- Device Class
- FDA class 2
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K992252 | LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 | Aug 10, 1999 | Substantially Equivalent | Chemicon Intl., Inc. |
| K923349 | FUNGI FLUOR KIT | Oct 20, 1992 | Substantially Equivalent | Polysciences, Inc. |
| K905504 | STAINING SYSTEM FOR PNEUMOCYSTIS CARINII | Jun 28, 1991 | Substantially Equivalent | Dako Corp. |
| K904400 | MERIFLUOR TM PNEUMOCYSTIS MODIFICATION | Oct 16, 1990 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K890768 | PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT | Mar 21, 1989 | Substantially Equivalent | Genetic Systems Corp. |
| K884047 | FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY | Mar 14, 1989 | Substantially Equivalent | Disease Detection International, Inc. |
| K881608 | MERIFLUOR(TM) PNEUMOCYSTIS | Aug 04, 1988 | Substantially Equivalent | Meridian Diagnostics, Inc. |
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.