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Urine Collection Kit (Excludes Hiv Testing)
FDA product code OIE · Class 1 · Pathology
65
Registered devices
10
Adverse events
1
Recalls
0
510(k) clearances
Devices with this code
PREGABLE Ovulation Test Kit — Equinox Biotech Co., Ltd.MEDICAL ACTION INDUSTRIES — MEDICAL ACTION INDUSTRIES INC.Emay — Equinox Biotech Co., Ltd.MEDLINE — MEDLINE INDUSTRIES, INC.RenalytixAI Urine Collection Kit — Renalytix Ai, Inc.Urine Raku-Ryu Cup — TAKAHASHI KEISEI CORPORATIONEverlywell Blood and Urine Collection Kit — Everly Health, Inc.Everlywell Urine Collection Kit — Everly Health, Inc.Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.US Urine Examiner Kit — Quest DiagnosticsRTL Urine Collection Kit — Realtime Laboratories, Inc.Medline — MEDLINE INDUSTRIES, INC.Recopad — Medfire Innovations Inc.VACUETTE — Greiner Bio-One GmbHMedical Action Industries — MEDICAL ACTION INDUSTRIES INC.DAVID — Equinox Biotech Co., Ltd.VACUETTE — Greiner Bio-One GmbHPlaySafe™ — RANDOX LABORATORIES LIMITEDEverlywell Urine Collection Kit — Everly Health, Inc.Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.Progensa — Hologic, Inc.DAVID OVULATION TEST KIT — Equinox Biotech Co., Ltd.SureStep Vacutainer Urine Sampling Kit — C. R. Bard, Inc.VACUETTE — Greiner Bio-One GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-04-17 | Gen-Probe Inc | 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 " |
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