Home › Device types › JIR
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
FDA product code JIR · Class 1 · Clinical Chemistry
237
Registered devices
37
Adverse events
7
Recalls
38
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 IncMission 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 DIAGNOSTICSDCA® Systems Microalbumin/Creatinine Capillary holders and plungers — Siemens Healthcare Diagnostics Inc.TECO DIAGNOSTICS — TECO DIAGNOSTICSRapid Response — BTNX IncHenry Schein — HENRY SCHEIN, INC.URiSCAN 2 ACR strip — YD Diagnostics CORP.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, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-06 | Siemens Healthcare Diagnostics, Inc. | processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea |
| 2026-04-02 | DFI Co., Ltd. | The devices were distributed without required FDA premarket clearance or approval. |
| 2026-01-20 | Siemens Healthcare Diagnostics, Inc. | Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report |
| 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; |
| 2024-08-22 | Healgen Scientific Llc | The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential fals |
| 2024-08-15 | Siemens Healthcare Diagnostics, Inc. | Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated |
| 2024-08-15 | Siemens Healthcare Diagnostics, Inc. | Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated |
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