Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-Hcg) Assay

• • Terminated Z-0007-06 FDA Unclassified (pre-2012) ·initiated 31 Aug 2005

  Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.

510(k) Number

K042676 ↗

FDA Product Code

DHA

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

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  Class II

  FDA 510(k) K980737 Active Cleared 23 Mar 1999

• Vitamin D Test System Nichols Advantage 25-Hydroxyvitamin D

  Class II

  FDA 510(k) K012367 Active Cleared 9 Oct 2001

• Nichols Advantage Chemiluminescence Adrenocorticotropic Hormone

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  FDA 510(k) K962601 Active Cleared 24 Dec 1996

• Aminoglycoside Test System

  Class II

  FDA 510(k) K780048 Active Cleared 20 Jan 1978

• Nichols Advantage Direct Renin (Calibrators, Calibration Verifiers, Controls, and Sample Diluent)

  Class II

  FDA 510(k) K011128 Active Cleared 6 Sep 2001

See all devices from Quest Diagnostics Nichols Institute →