Uric Acid Pap

• • Terminated Z-1931-2015 FDA Class II ·initiated 7 May 2015

  Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.

510(k) Number

K873363 ↗

FDA Product Code

KNK

Device Class

Class I

Regulation

21 CFR Part 862.1775

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Boehringer Mannheim Corp. →