Serim Disintek Opa Test Strip
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081370 FDA 510(k)
- FDA Product Code
- JOJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Serim Disintek Opa Test Strip is an indicator device for physical/chemical sterilization processes. It is used to detect the presence of ortho-phthalaldehyde (OPA) in high-level disinfectants.
The test strip is supplied non-sterile for single-use in general hospital settings. It has received FDA 510(k) clearance under product code JOJ and regulation number 880.2800.
Frequently asked questions
What is the Serim Disintek Opa Test Strip used for?
The Serim Disintek Opa Test Strip is an indicator device used to detect the presence of ortho-phthalaldehyde (OPA) in high-level disinfectants, helping monitor the effectiveness of physical/chemical sterilization processes in general hospital environments.
Is the Serim Disintek Opa Test Strip sterile or non-sterile, and is it for single-use or reuse?
The test strip is supplied non-sterile and is intended for single-use only in general hospital settings, as specified in the device description, to ensure reliable detection of OPA without cross-contamination risks.
What regulatory pathway was used for the Serim Disintek Opa Test Strip, and what is its product code?
The device received FDA 510(k) clearance under product code JOJ and regulation number 880.2800, with a traditional clearance type and a substantially equivalent decision based on its indication as an indicator for physical/chemical sterilization processes.
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: Serim - The Test Strip Specialists
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081370 | Class II | Active |
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Manufacturer
- Manufacturer
- Serim Research Corp.
Sources (1)
- FDA 510(k) K081370 24 fields · synced Sep 23, 2026