Legionella Differentiation Disk
FDA 510(k)Class II (US FDA 510(k))
by Remel Co.
Identifiers
- 510(k) Number
- K834067 FDA 510(k)
- FDA Product Code
- GRO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3300 FDA 510(k)
- Regulation Number
- 866.3300 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Legionella Differentiation Disk is a fluorescent antisera diagnostic tool used for identifying Legionella species in microbiological testing. Classified under the category of antisera for fluorescent applications, it aids in the differentiation of Legionella bacteria from other microorganisms, supporting accurate identification in clinical and research settings.
This device is supplied as a single-use diagnostic reagent, intended for use in microbiology laboratories. It is regulated under FDA 510(k) clearance (K834067) with a classification as Class II (device code GRO, regulation 866.3300). The disk is designed for fluorescent microscopy and requires proper storage to maintain efficacy, adhering to standard microbiological laboratory practices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LEGIONELLA DIFFERENTIATION DISK (K834067) — FDA 510 (k) | Innolitics, K834067 - LEGIONELLA DIFFERENTIATION DISK | FDA 510(k), Legionella Differentiation Disk 510 (k) K834067 - FDA.report, PDF K834067 - Legionella Differentiation Disk, PDF BUFFERED CYE (BCYE) DIFFERENTIAL AGAR w/ and w/o PAV
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K834067 | Class II | Active |
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Manufacturer
- Manufacturer
- Remel Co.
Sources (1)
- FDA 510(k) K834067 24 fields · synced Oct 1, 2026