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ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM - Bm-2-1

by Bioscreen Medical, Inc.

510(k) K050305

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050305 Date23 May 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LCX
Models / Variants
Bm-2-1
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The One Step HCG Pregnancy Urine Test is a device used to detect human chorionic gonadotropin (HCG) in urine, indicating pregnancy. It is available in three formats: strip, cassette, and midstream, with models BM-1-1, BM-1-2, BM-1-3, BM-2-1, and BM-2-2. This test is designed for over-the-counter use and falls under the clinical chemistry category.

The device is supplied in various formats and is intended for single-use. It is not MRI compatible and should be stored according to the manufacturer's instructions. The device has received FDA 510(k) clearance with the product code LCX and is classified as a Class II medical device. The manufacturer is Bioscreen Medical, Inc., and the device is authorized for distribution in the United States.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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

    The One Step HCG Pregnancy Urine Test is designed to detect human chorionic gonadotropin (HCG) in urine, which indicates pregnancy. It is available in three formats: strip, cassette, and midstream, with models BM-1-1, BM-1-2, BM-1-3, BM-2-1, and BM-2-2.

  • How is the One Step HCG Pregnancy Urine Test supplied and is it reusable?

    The device is supplied in various formats including strip, cassette, and midstream. It is intended for single-use only and should not be reused. Each test is designed to be used once for accurate results.

  • What are the storage requirements for this pregnancy test?

    The One Step HCG Pregnancy Urine Test should be stored according to the manufacturer's instructions. It is not MRI compatible, so proper storage conditions must be followed to maintain the integrity of the test until use.

  • What is the regulatory status of the One Step HCG Pregnancy Urine Test?

    The device has received FDA 510(k) clearance with the product code LCX and is classified as a Class II medical device. It is authorized for distribution in the United States and falls under the clinical chemistry category.