Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
A coagglutination antiserum for direct detection of Neisseria gonorrhoeae is a microbiological reagent used to identify the presence of Neisseria gonorrhoeae in clinical specimens through the coagglutination technique, in which antibodies bound to protein A-bearing staphylococci agglutinate in the presence of the target antigen. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LIC and is regulated under 21 CFR 866.3390 within the Microbiology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- LIC
- Device Class
- FDA class 2
- Regulation Number
- 866.3390
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K921075 | PHADEBACT MONOCLONAL GC TEST, MODIFICATION | May 22, 1992 | Substantially Equivalent | Karo Bio Diagnostics AB |
| K911430 | IDEIA(TM) CHLAMYDIA, MODIFICATION | Aug 07, 1991 | Substantially Equivalent | Novo Nordisk Diagnostics, Ltd. |
| K880076 | G-MARK | Jul 01, 1988 | Substantially Equivalent | Bainbridge Laboratories, Inc. |
| K874078 | MERITEC(TM)-GC | Dec 09, 1987 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K871105 | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE | May 13, 1987 | Substantially Equivalent | New Horizons Diagnostics Co. |
| K851650 | PHADEBACT MONOCLONAL GC OMNI TEST | Jul 12, 1985 | Substantially Equivalent | Pharmacia, Inc. |
| K850351 | PHADEBACT MONOCLONAL GC TEST | Mar 13, 1985 | Substantially Equivalent | Pharmacia, Inc. |
| K821362 | IMPROVED GONO GEN | Aug 04, 1982 | Substantially Equivalent | New Horizons Diagnostics Co. |
| K820007 | NEISSERIA GONORRHOEAE TEST | Jan 29, 1982 | Substantially Equivalent | New Horizons Diagnostics Co. |