Antisera, Fluorescent, Chlamydia Spp.
Antisera, Fluorescent, Chlamydia Spp. are fluorescent-labeled antisera used in immunofluorescence assays to detect and identify Chlamydia species in clinical specimens, supporting diagnosis of chlamydial infections including respiratory and genital tract infections. This device is classified as FDA Class 1, the lowest risk category, requiring only general controls. The product code is LKI, regulated under 21 CFR 866.3120, within the Microbiology medical specialty. This device is eligible for third-party 510(k) review.
Basic Information
- Product Code
- LKI
- Device Class
- FDA class 1
- Regulation Number
- 866.3120
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K914953 | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY | Feb 19, 1992 | Substantially Equivalent | Stellar Bio Systems, Inc. |
| K905531 | LUPUS(LE)-LATEX TEST | Jan 25, 1991 | Substantially Equivalent | Immco Diagnostics, Inc. |
| K894625 | CHLAMYDIA (LGV-1) | Aug 15, 1989 | Substantially Equivalent | Bion Ent., Ltd. |
| K883776 | BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE | Feb 03, 1989 | Substantially Equivalent | Btc Corp. |
| K854615 | MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES | Jan 28, 1986 | Substantially Equivalent | Serono Diagnostics, Inc. |
| K830342 | CULUTURE SET CHLAMYDIA ISOLATION AND | May 04, 1983 | Substantially Equivalent | Immulok, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.