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Paper, Obstetric Ph
FDA product code LNW · Class 1 · Clinical Chemistry
25
Registered devices
5
Adverse events
2
Recalls
4
510(k) clearances
Devices with this code
T Testahead Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd.Exploro Vaginal Health pH Test Device — Safecare Biotech (Hangzhou) Co., Ltd.Safecare Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd.Exploro Vaginal Health pH Test Device — Safecare Biotech (Hangzhou) Co., Ltd.Exploro Vaginal Health pH Test Device — Safecare Biotech (Hangzhou) Co., Ltd.Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd.Exploro Vaginal Health pH Test Device — Safecare Biotech (Hangzhou) Co., Ltd.McKesson — MCKESSON MEDICAL-SURGICAL INC.Henso — Henso Medical (Hangzhou) Co., Ltd.Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd.T Testahead Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd.Winx Health Inc — Get Stix Inc.Gynex — GYNEX CORPORATIONWelcheck Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd.Safecare Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd.Teco Diagnostics Vaginal pH Screening Kit — TECO DIAGNOSTICSWelcheck Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd.Easy@home Feminine Vaginal pH Test Strip(10 tests) — EASY HEALTHCARE CORPORATIONExploro Vaginal Health pH Test Device — Safecare Biotech (Hangzhou) Co., Ltd.Welcheck Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd.GenaCheck Vaginal pH Screening Test — Genabio Diagnostics Inc.Testahead Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd.Easy@home Feminine Vaginal pH Test Strip(30 tests) — EASY HEALTHCARE CORPORATIONVaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-22 | Changchun Wancheng Bio-Electron Co., Ltd. | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; |
| 2003-08-28 | Instrumentation Laboratory Co. | Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L. |
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