OIEClass I

Urine Collection Kit (excludes Hiv Testing)

Pathology · 21 CFR 864.3250

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

MDR events10All time

Recalls1All time

Registered firms46Currently listed

510(k) clearances0All time

Recent MDR events

10 adverse event reports on file

Event type breakdown

Malfunction10

Most-reported manufacturers

Unknown4 Bard Medical1 Becton Dickinson & Co (franklin Lakes)1 Becton, Dickinson & Co.1 Becton, Dickinson & Co. (broken Bow)1 Becton, Dickinson And Company1 Doctor's Data Inc.1

Recalls

1 recall events for this product code

Gen-Probe Inc
TerminatedJun 14, 2014
APTIMA Urine Collection Kit; Catalog Number
Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collection Kits"; however, the inner pouches are incorrectly labeled as "APTIMA Unisex Swab Collection Kit for Endocervical and Male Urethral Swab Specimens."
Z-1793-2014 · View FDA record ↗

Registered firms

46 firms currently registered for this product code

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.