Home › Device types › JIN
Nitroprusside, Ketones (Urinary, Non-Quant.)
FDA product code JIN · Class 1 · Clinical Chemistry
261
Registered devices
187
Adverse events
14
Recalls
24
510(k) clearances
Devices with this code
Mission Urinalysis Reagent Strips — Acon Laboratories, Inc.Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System — TECO DIAGNOSTICSMission Urinalysis Reagent Strips — Acon Laboratories, Inc.Multistix® 8 SG Reagent Strips — Siemens Healthcare Diagnostics Inc.Moore Medical — MOORE MEDICAL LLCRapid Response — BTNX IncSTAT-Site Diluent — STANBIO LABORATORY, L.P.KetoBM — Ketobm LLCTECO DIAGNOSTICS — TECO DIAGNOSTICSMission Urinalysis Reagent Strips — Acon Laboratories, Inc.TECO DIAGNOSTICS — TECO DIAGNOSTICSAccustrip URS Strips + Reader — JANT PHARMACAL CORPORATIONTECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICSURiSCAN 10 SGL strip — YD Diagnostics CORP.Bruno — BRUNO PHARMA INNOVATIONS, LLCMedline — MEDLINE INDUSTRIES, INC.KetoSens — i-SENS, Inc.STAT-Site Linearity Check — STANBIO LABORATORY, L.P.Easy@Home KetoneTest Strips (100 test kit) — EASY HEALTHCARE CORPORATIONTECO DIAGNOSTICS — TECO DIAGNOSTICSRapid Response — BTNX IncEasy@Home Ketone Test Strips (50 Pack) — EASY HEALTHCARE CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-02 | DFI Co., Ltd. | The devices were distributed without required FDA premarket clearance or approval. |
| 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; |
| 2023-10-02 | Stanbio Laboratory, LP | Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The r |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2022-03-08 | MEDLINE INDUSTRIES, LP - Northfield | Product was improperly store which may cause a delay in results. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
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