Ventrex Coated Tube HCG

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

510(k) Number

K890549 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ventrezyme Vast Immuno-Peroxidase Assay

  Class II

  FDA 510(k) K880547 Active Cleared 25 Mar 1988

• Ace Activity Microvial Test Set

  Class II

  FDA 510(k) K821011 Active Cleared 3 May 1982

• Centria T3 Uptake Test Set

  Not classified

  FDA 510(k) K791050 Active Cleared 15 Jun 1979

• Ventrescreen, Multiple Allergen Discs

  Class II

  FDA 510(k) K841516 Active Cleared 11 May 1984

• Coated Tube HCG Immunoassay HCG

  Class II

  FDA 510(k) K841023 Active Cleared 1 May 1984

• Ventrezyme Beta-Hcg Immunoassay Hcg

  Class II

  FDA 510(k) K841081 Active Cleared 7 May 1984

See all devices from Ventrex Laboratories, Inc. →

• What is the Ventrex Coated Tube HCG used for in a clinical setting?

  The Ventrex Coated Tube HCG is designed for visual pregnancy testing to detect human chorionic gonadotropin (hCG) in urine samples. It is intended for use in clinical laboratory settings to assist in confirming pregnancy through in vitro diagnostic testing.

• Is the Ventrex Coated Tube HCG sterile, and how is it supplied?

  The Ventrex Coated Tube HCG is supplied as a non-sterile, single-use reagent tube. Since it is intended for in vitro diagnostic use, it is packaged individually for one-time application to ensure accuracy and prevent cross-contamination.

• Can this device be reused, or is it intended for single-use only?

  Yes, the Ventrex Coated Tube HCG is explicitly designed for single-use only. This ensures reliable test results and maintains the integrity of the coated reagent, which may degrade or become contaminated with repeated use.

• What regulatory pathway was followed for FDA clearance of this device?

  The Ventrex Coated Tube HCG received FDA 510(k) clearance (K890549) under the traditional review process, demonstrating substantial equivalence to a predicate device. It is classified under 21 CFR 862.1155 and falls under the product code JHI, regulated for clinical chemistry applications.

• Are there multiple sizes or models of the Ventrex Coated Tube HCG, or is it available in a single configuration?

  The provided data does not specify multiple sizes or models, but the device is listed under multiple FEI numbers (e.g., 3013332582, 3003102569), which may indicate variations in packaging or lot-specific identifiers. However, the core design remains consistent for visual hCG detection in urine samples.