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Urine Collection Kit (Excludes Hiv Testing)
FDA product code OIE · Class 1 · Pathology
65
Registered devices
11
Adverse events
2
Recalls
0
510(k) clearances
Devices with this code
Progensa — Hologic, Inc.PREGABLE Ovulation Test Kit — Equinox Biotech Co., Ltd.Smilereader ovulation test kit — Equinox Biotech Co., Ltd.Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.DAVID — Equinox Biotech Co., Ltd.VACUETTE — Greiner Bio-One GmbHUS Biotek Laboratories — U.S. Biotek Laboratories LLCMEDICAL ACTION INDUSTRIES — MEDICAL ACTION INDUSTRIES INC.Everlywell Urine Collection Kit — Everly Health, Inc.Recopad — Medfire Innovations Inc.Medline — MEDLINE INDUSTRIES, INC.Therapak — Therapak LLCUrine Raku-Ryu Cup — TAKAHASHI KEISEI CORPORATIONINDICAID health Sexual Health 2 — Phase Diagnostics, Inc.VACUETTE — Greiner Bio-One GmbHLetsGetChecked Urine Sample Collection Kit (UACR/UACRL) — PRIVAPATH DIAGNOSTICS LIMITEDAFAC One Step HCG and Ovulation Urine test Kit — Equinox Biotech Co., Ltd.Urine Raku-Ryu Cup — TAKAHASHI KEISEI CORPORATIONMedical Action Industries — MEDICAL ACTION INDUSTRIES INC.Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.MEDICAL ACTION INDUSTRIES — MEDICAL ACTION INDUSTRIES INC.Everlywell Urine Collection Kit — Everly Health, Inc.Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.Kidney Stone Transportation Kit — Ditek Consulting, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-09 | Medical Action Industries, Inc. 306 | An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027. |
| 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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