Ministrip HCG

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K951705 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• One Step Midstream Hcg Pregnancy Test Open recall

  Class II

  FDA 510(k) K974059 Active Cleared 9 Apr 1998

• Mini Strip/Serum Hcg Open recall

  Class II

  FDA 510(k) K963132 Active Cleared 18 Nov 1996

• Ps-Unit Cassette/Serum and Urine Combo Hcg

  Class II

  FDA 510(k) K974009 Active Cleared 13 Mar 1998

• Urinalysis Reagent Strips (10 Parameters) Open recall

  Class I

  FDA 510(k) K993850 Active Cleared 3 Jan 2000

• Ministrip/ Serum and Urine Combo Hcg Test

  Class II

  FDA 510(k) K974060 Active Cleared 9 Apr 1998

• Ps-Unit Cassette/Serum Hcg Open recall

  Class II

  FDA 510(k) K963133 Active Cleared 18 Nov 1996

See all devices from International Newtech Development, Inc. →

• What is the Ministrip HCG used for?

  The Ministrip HCG is a visual pregnancy test designed to detect the presence of human chorionic gonadotropin (hCG) in urine or serum samples. hCG is a hormone produced during pregnancy, so this device provides a qualitative result to confirm pregnancy. It operates as a lateral flow immunoassay, showing a visible color change on the test strip to indicate a positive or negative result.

• Is the Ministrip HCG sterile and single-use?

  The Ministrip HCG is supplied as a single-use diagnostic tool and is classified as non-sterile. It is intended for in vitro use in clinical chemistry settings, meaning it is not sterile but is designed for one-time use per test strip to ensure accuracy and reliability.

• What reference codes or lot numbers are associated with the Ministrip HCG?

  The Ministrip HCG is available with multiple reference codes and lot numbers for traceability, including but not limited to: 3013332582, 3003102569, 3006198300, 3005216656, 3030413233, and others listed in the FDA’s OpenFDA database. These codes help track specific batches and ensure regulatory compliance.

• How should the Ministrip HCG be stored?

  Storage conditions for the Ministrip HCG must comply with the manufacturer’s guidelines to maintain accuracy and reliability. While the exact storage instructions are not detailed in the provided data, typical lateral flow immunoassay devices require protection from extreme temperatures, moisture, and direct sunlight. Always refer to the accompanying documentation for precise storage recommendations.

• What regulatory pathway does the Ministrip HCG follow?

  The Ministrip HCG is regulated under the FDA’s 510(k) clearance process and is classified as a Class II medical device. It was granted clearance through a traditional 510(k) submission, with a decision date of October 3, 1995. The device is also categorized under the Clinical Chemistry advisory committee and falls under the product code JHI.