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EGENS ONE STEP HCG URINE PREGNANCY TEST KIT - Cassette

FDA 510(k)

Class II (US FDA 510(k))

510(k) K123050

by Nantong Biotechnology Co., Ltd.

Identifiers

510(k) Number
K123050 FDA 510(k)
FDA Product Code
LCX FDA 510(k)
Models / Variants
strip FDA 510(k)
Cassette FDA 510(k)
Midstream I And Midstream Ii 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 Egens One Step Hcg Urine Pregnancy Test Kit is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples. It is used to aid in the early detection of pregnancy. The device is available in different formats, including strip, cassette, midstream I, and midstream II.

The test kit is supplied for both professional and home use. It is classified as a Kit, Test, Pregnancy, Hcg, with a regulation number of 862.1155 and a product code of LCX. The device has been found to be substantially equivalent, with an FDA 510K number of K123050, and a decision date of 2013-02-05.

Frequently asked questions

What is the Egens One Step HCG Urine Pregnancy Test Kit used for?

The Egens One Step HCG Urine Pregnancy Test Kit is used for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy.

What formats is the Egens One Step HCG Urine Pregnancy Test Kit available in?

The Egens One Step HCG Urine Pregnancy Test Kit is available in different formats, including strip, cassette, midstream I, and midstream II.

Is the Egens One Step HCG Urine Pregnancy Test Kit for professional or home use?

The Egens One Step HCG Urine Pregnancy Test Kit is supplied for both professional and home use.

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: HCG - Nantong Egens Biotechnology Co.,LTD, EGENS ONE STEP HCG URINE PREGNANCY TEST KIT (S)… - FDA.report, PDF DECISION SUMMARY A. 510(k) Number - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nantong Biotechnology Co., Ltd.

Sources (1)

  • FDA 510(k) K123050 24 fields · synced Oct 6, 2026