Stanbio Quick-Tell Monoclonal Indirect
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K842544 FDA 510(k)
- FDA Product Code
- JHJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1155 FDA 510(k)
- Regulation Number
- 862.1155 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stanbio Quick-Tell Monoclonal Indirect is an agglutination method device used for the detection of human chorionic gonadotropin. It functions as a diagnostic tool within the field of clinical chemistry.
This device is regulated under FDA 510(k) clearance K842544. It is classified as a class 2 medical device under regulation number 862.1155.
Frequently asked questions
What is the primary function of the Stanbio Quick-Tell Monoclonal Indirect?
This device is a diagnostic tool used within clinical chemistry settings to detect the presence of human chorionic gonadotropin through an agglutination method.
What is the regulatory status of this device?
The Stanbio Quick-Tell Monoclonal Indirect is regulated under FDA 510(k) clearance number K842544 and is classified as a class 2 medical device under regulation number 862.1155.
Which medical specialty is this device associated with?
This device is categorized under the clinical chemistry medical specialty, as it is designed to assist in laboratory diagnostic testing procedures.
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: STANBIO QUICK-TELL MONOCLONAL INDIRECT - Innolitics, PDF K842544 - Stanbio Quick-tell Monoclonal Indirect, Stanbio Laboratory FDA Filings, Stanbio Laboratory | Fisher Scientific, FDA Product Code JHJ - Agglutination Method, Human Chorionic Gonadotropin
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K842544 | Class II | Active |
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Manufacturer
- Manufacturer
- Stanbio Laboratory
Sources (1)
- FDA 510(k) K842544 24 fields · synced Sep 23, 2026