Ez-Bead Theophylline Enzyme Immunoassay Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K881257 FDA 510(k)
- FDA Product Code
- KLS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3880 FDA 510(k)
- Regulation Number
- 862.3880 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ez-Bead Theophylline Enzyme Immunoassay Kit is an enzyme immunoassay device used for the determination of theophylline. It is classified as a class 2 device and is used in the field of clinical toxicology. The device is substantially equivalent to other devices on the market.
The kit is supplied with a product code of KLS and is regulated under regulation number 862.3880. It was cleared for use on May 27, 1988, with FDA 510(k) clearance number K881257. The device is intended for use in a clinical setting and is not specified as single-use or reusable. Storage and handling instructions are not provided in the device data.
Frequently asked questions
What is the Ez-Bead Theophylline Enzyme Immunoassay Kit used for?
The Ez-Bead Theophylline Enzyme Immunoassay Kit is used for the determination of theophylline in clinical toxicology settings.
Is the Ez-Bead Theophylline Enzyme Immunoassay Kit single-use or reusable?
The device is not specified as single-use or reusable in the provided data.
What is the product code for the Ez-Bead Theophylline Enzyme Immunoassay Kit?
The product code for the Ez-Bead Theophylline Enzyme Immunoassay Kit is KLS.
What regulation number does the Ez-Bead Theophylline Enzyme Immunoassay Kit fall under?
The Ez-Bead Theophylline Enzyme Immunoassay Kit is regulated under regulation number 862.3880.
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: Ez-bead Theophylline Enzyme Immunoassay Kit, Ez-bead Theophylline Enzyme Immunoassay Kit - Beudamed, EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT 510(k) K881257 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K881257 | Class II | Active |
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Manufacturer
- Manufacturer
- Immunotech Corp.
Sources (1)
- FDA 510(k) K881257 24 fields · synced Sep 26, 2026