Cobas FP Reagents For Carbamazepine

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K850807 ↗

FDA Product Code

KLT

Device Class

Class II

Regulation

21 CFR Part 862.3645

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Roche Diagnostic Systems, Inc. →

• What is the purpose of COBAS FP Reagents for Carbamazepine?

  This device is an in vitro enzyme immunoassay designed for the quantitative determination of carbamazepine concentrations in serum and plasma. It is primarily used for monitoring therapeutic drug levels in clinical settings.

• How is the COBAS FP Reagents for Carbamazepine supplied?

  The device is supplied as laboratory reagents for use on cobas c systems. It is intended for single-use applications and should be handled according to the manufacturer's instructions.

• What is the regulatory classification of this device?

  COBAS FP Reagents for Carbamazepine is classified as a Class II medical device with FDA 510(k) clearance K850807, cleared on March 22, 1985, for use in clinical toxicology settings.

• Are there any special storage requirements for this device?

  Yes, the device should be stored according to the manufacturer's instructions. It is not MRI compatible, so proper storage conditions must be maintained to ensure test accuracy and reliability.