Home › Device types › JIL
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
FDA product code JIL · Class 2 · Clinical Chemistry
232
Registered devices
547
Adverse events
7
Recalls
81
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 IncTECO DIAGNOSTICS — TECO DIAGNOSTICSMission Urinalysis Reagent Strips — Acon Laboratories, Inc.TECO DIAGNOSTICS — TECO DIAGNOSTICSAccustrip URS Strips + Reader — JANT PHARMACAL CORPORATIONTECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICSURiSCAN 10 SGL strip — YD Diagnostics CORP.Medline — MEDLINE INDUSTRIES, INC.Mission Urinalysis Reagent Strips — Acon Laboratories, Inc.TECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICSRapid Response — BTNX IncHenry Schein — HENRY SCHEIN, INC.Mission Urinalysis Reagent Strips — Acon Laboratories, Inc.CLINITEK Novus® 10 Urinalysis Cassette 450 — Siemens Healthcare Diagnostics Inc.Mission Urinalysis Reagent Strips — Acon Laboratories, Inc.CARDINAL HEALTH — Cardinal Health 200, LLCMission Urinalysis Reagent Strips — Acon Laboratories, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2024-04-04 | Macherey Nagel Gmbh & Co. Kg | The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer |
| 2016-07-15 | Roche Diagnostics Operations, Inc. | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sam |
| 2014-12-08 | Beckman Coulter Inc. | Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative. |
| 2014-09-19 | Siemens Healthcare Diagnostics, Inc | The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User. |
| 2014-09-19 | Siemens Healthcare Diagnostics, Inc | The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User. |
| 2014-09-19 | Siemens Healthcare Diagnostics, Inc | The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User. |
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