Beckman Direct Bilirubin Reagent

• • Terminated Z-1425-2020 FDA Class II ·initiated 15 Aug 2019

  It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.

510(k) Number

K934068 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Vigil Prx Chemistry Control

  Class I

  FDA 510(k) K936184 Active Cleared 15 Apr 1994

• Cx Phencyclidine Reagent for Synschron Cx System

  Unclassified

  FDA 510(k) K944605 Active Cleared 7 Dec 1994

• Synchron CX3 Delta

  Class I

  FDA 510(k) K942676 Active Cleared 2 Nov 1994

• Beckman Pancreatic Amylase (Pamy) Reagent

  Class II

  FDA 510(k) K934293 Active Cleared 6 Jul 1994

• Beckman Synchron Lactate Reagent

  Class I

  FDA 510(k) K934271 Active Cleared 9 Nov 1993

• I.D.-Zone Immunofixation Electrophoresis Controls

  Class II

  FDA 510(k) K945522 Active Cleared 12 Dec 1994

See all devices from Beckman-Diagnostic Systems Group →