Dye-Indicator, Ph (Urinary, Non-Quantitative)
FDA product code CEN · Class I (low risk) · 21 CFR 862.1550 · Clinical Chemistry
11510(k) clearances
0PMA approvals
5recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091287 | Vs-Sense TestCEN · Traditional | Common Sense , Ltd. | 08/31/2009SE |
| K071100 | Amniscreen Home Detection Liner KitCEN · Traditional | Common Sense , Ltd. | 10/15/2007SE |
| K051727 | Aimstick Urine Reagent StripsCEN · Traditional | Germaine Laboratories, Inc. | 10/26/2005SE |
| K040008 | Quickvue Advance PH and Amines GLL TestCEN · Traditional | Quidel Corp. | 04/29/2004SE |
| K030650 | Stoneguard II Reagent Strips for Urinalysis and Confirm Control SolutionsCEN · Traditional | Uridynamics, Inc. | 04/14/2003SE |
| K962718 | Femexam TestcardCEN · Traditional | Litmus Concepts, Inc. | 02/07/1997SE |
| K840827 | Kyotest 5VCEN · Traditional | Kyoto Diagnostics, Inc. | 05/14/1984SE |
| K830824 | Urine Screening KitCEN · Traditional | Syn-Kit, Inc. | 06/12/1983SE |
| K830979 | Helena Biostrip PHCEN · Traditional | Helena Laboratories | 05/05/1983SE |
| K830091 | Lith a Test TMCEN · Traditional | Lenal Creative Approaches, Inc. | 02/15/1983SE |
| K822241 | FOLATE/B12 Duo-Bead RadioassayCEN · Traditional | Abbott Laboratories | 10/26/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2084-2026 Class II | One Step pH in vitro diagnostic test REF: 31I4PThe devices were distributed without required FDA premarket clearance or approval. | DFI Co., Ltd. | 04/02/2026Open, Classified |
| Z-1264-2026 Class II | Vivoo pH TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed… | Changchun Wancheng Bio-Electron Co., Ltd. | 11/22/2025Open, Classified |
| Z-0767-2026 Class II | Organic Acids Profile Test LargeDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0755-2026 Class II | Vaginal PH TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0047-2024 Class II | HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIPUniversal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |