Home › Device types › JIR
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
FDA product code JIR · Class 1 · Clinical Chemistry
252
Registered devices
44
Adverse events
7
Recalls
38
510(k) clearances
Devices with this code
Accutest — JANT PHARMACAL CORPORATIONRapid Response — BTNX IncTECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICSMoore Medical — MOORE MEDICAL LLCYodoc 10 — DFI CO.,LTDTECO DIAGNOSTICS — TECO DIAGNOSTICSUrine Reagent Strips, 10-parameter — LW SCIENTIFIC, INC.URINE REAGENT STRIPS — Urit Medical Electronic Co., Ltd.Urine Reagent Strips — Urit Medical Electronic Co., Ltd.Clinistix Kidney Health Test System — Siemens Healthcare Diagnostics Inc.McKesson — MCKESSON MEDICAL-SURGICAL INC.TECO DIAGNOSTICS — TECO DIAGNOSTICSMission Urinalysis Reagent Strips — Acon Laboratories, Inc.Mission Urinalysis Reagent Strips — Acon Laboratories, Inc.AUTION™ MAX AX-4022 Analyzer — ARKRAY USA, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.Urine Chemistry Strips — Urit Medical Electronic Co., Ltd.TECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICSAIMSTRIP US-4 — GERMAINE LABORATORIES, INCMission Urinalysis Reagent Strips — Acon Laboratories, Inc.TECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICS
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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