Ciba Corning ACS HCG Immunoassay

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

510(k) Number

K904123 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Ciba Corning Diagnostics Corp. →

• What is the Ciba Corning ACS HCG Immunoassay used for?

  The Ciba Corning ACS HCG Immunoassay is a clinical chemistry device designed to detect human chorionic gonadotropin (HCG) in patient samples to aid in the diagnosis of pregnancy. It is intended for prescription use in clinical laboratory settings.

• How is the Ciba Corning ACS HCG Immunoassay supplied?

  The device is supplied for prescription use and is classified as a Class II medical device. It requires appropriate storage conditions as specified by the manufacturer to maintain its integrity and performance for clinical laboratory testing.

• What is the regulatory status of the Ciba Corning ACS HCG Immunoassay?

  The device is authorized under FDA 510K clearance with the product code JHI. It has been determined to be substantially equivalent to other predicate devices in its class, making it suitable for clinical laboratory use in pregnancy testing.

• What are the specifications of the Ciba Corning ACS HCG Immunoassay?

  The device is a clinical chemistry immunoassay specifically designed for measuring HCG levels in patient samples. It is manufactured by Ciba Corning Diagnostics Corp. and is intended for use in clinical laboratory settings with appropriate storage conditions maintained as per manufacturer guidelines.