Urine Culture Kit

• • Terminated Z-0491-2019 FDA Class II ·initiated 30 Aug 2018

  BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.

• • Terminated Z-1026-2010 FDA Unclassified (pre-2012) ·initiated 12 Oct 2009

  A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes.

510(k) Number

K790366 ↗

FDA Product Code

JTW

Device Class

Class I

Regulation

21 CFR Part 866.2900

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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