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Quantitative Determination of HCG in Serum-ELISA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K853925

by Nms Pharmaceuticals, Inc.

Identifiers

510(k) Number
K853925 FDA 510(k)
FDA Product Code
JHI 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 Quantitative Determination of HCG in Serum-ELISA is an enzyme immunoassay kit used for the quantitative measurement of Human Chorionic Gonadotropin in serum samples. This device utilizes 96-well plates and a microplate reader to perform the analysis, with specialized software facilitating data processing for both qualitative and quantitative results.

The device is supplied as a research-use-only kit and is intended for laboratory settings. It is a Class II medical device cleared by the FDA through the 510(k) process with K853925, specifically for clinical chemistry applications. The device is not MRI safety rated and is not specified as single-use or reusable in the provided data.

Frequently asked questions

What is the purpose of the Quantitative Determination of HCG in Serum-ELISA?

This enzyme immunoassay kit is designed for the quantitative measurement of Human Chorionic Gonadotropin (HCG) in serum samples. It utilizes 96-well plates and a microplate reader to perform analysis, with specialized software facilitating data processing for both qualitative and quantitative results.

How is the HCG ELISA kit supplied and what is its intended use?

The device is supplied as a research-use-only kit intended for laboratory settings. It is a Class II medical device cleared by the FDA through the 510(k) process with K853925, specifically for clinical chemistry applications.

Is the HCG ELISA kit single-use or reusable?

The provided data does not specify whether the device is single-use or reusable. The device is not MRI safety rated according to the information provided.

What regulatory status does the HCG ELISA kit have?

The device is a Class II medical device cleared by the FDA through the 510(k) process with K853925. It is substantially equivalent to other devices in its product code category JHI for clinical chemistry applications.

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: QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA 510 (k) K853925 - FDA ..., Quantitative Determination of Hcg in Serum-elisa_k853925_nms ..., Human Chorionic Gonadotropin ELISA - HCG - United Immunoassay, An enzyme immunoassay to determine human chorionic gonadotropin (HCG ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nms Pharmaceuticals, Inc.

Sources (1)

  • FDA 510(k) K853925 24 fields · synced Sep 22, 2026