Test Reagents, Neisseria Gonorrhoeae Biochemical
The Neisseria Gonorrhoeae Biochemical Test Reagents (product code LTS) are diagnostic microbiology reagents used to identify Neisseria gonorrhoeae, the bacterium responsible for gonorrhea, through biochemical testing methods. Regulated under 21 CFR 866.2660 and classified as a Class 1 device, these reagents are subject only to general controls and are not exempt from Good Manufacturing Practice requirements. They fall within the Microbiology medical specialty. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- LTS
- Device Class
- FDA class 1
- Regulation Number
- 866.2660
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K954784 | DRYSIDE NEISSERIA | Jan 30, 1996 | Substantially Equivalent | Difco Laboratories, Inc. |