Alere i Instrument, Alere i Influenza A & B, Alere i Strep A
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151690 FDA 510(k)
- FDA Product Code
- OOI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.2570 FDA 510(k)
- Regulation Number
- 862.2570 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Alere i Instrument is a real-time nucleic acid amplification system designed for the qualitative detection of specific nucleic acids. It is used for the detection of Influenza A and B, and Streptococcus pyogenes from throat swab specimens.
The device is supplied as a single-use instrument and consumables. It is intended for use in a clinical laboratory setting. The device is not sterile and requires storage at controlled room temperature.
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: Alere i Instrument, Alere i Influenza A & B, Alere i Strep A, PDF Alere i brochure - Cardinal Health, Influenza POC analyzer / PCR Alere™ i Influenza A & B Alere
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151690 | Class II | Active |
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Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA 510(k) K151690 24 fields · synced Oct 6, 2026