CR3 Keyless Split Sample Cup (OPI-BZO)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140089 FDA 510(k)
- FDA Product Code
- DJG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3650 FDA 510(k)
- Regulation Number
- 862.3650 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CR3 Keyless Split Sample Cup (OPI-BZO) is a lateral flow immunochromatographic assay for the qualitative detection of Morphine and Oxazepam in human urine. It operates on a competitive binding principle and is intended for use in clinical toxicology settings.
The device is supplied as a single-use, non-sterile item and does not require storage at specific temperatures. It is not intended for use in an MRI environment. The device is regulated as a Class II medical device and has received FDA 510(k) clearance.
Frequently asked questions
What is the CR3 Keyless Split Sample Cup (OPI-BZO) used for?
This device is a lateral flow immunochromatographic assay designed for the qualitative detection of Morphine and Oxazepam in human urine. It is intended for use in clinical toxicology settings.
How is the CR3 Keyless Split Sample Cup supplied and is it sterile?
The device is supplied as a single-use, non-sterile item. It does not require storage at specific temperatures.
What is the regulatory status of the CR3 Keyless Split Sample Cup?
The CR3 Keyless Split Sample Cup is regulated as a Class II medical device and has received FDA 510(k) clearance.
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: CR3 KEYLESS SPLIT SAMPLE CUP (OPI-BZO) - Innolitics, Wondfo CR3 Keyless Split Sample Cup by GUANGZHOU WONDFO BIOTECH CO ..., Wondfo CR3 Keyless Split Sample Cup (K151478) - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140089 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
Sources (1)
- FDA 510(k) K140089 24 fields · synced Oct 6, 2026