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Uri-Chek 10SG Strips

STANBIO LABORATORY, L.P. · Model 1280-100 · UDI-DI 00657498000052

CDM Prescription
9
510(k) clearances
21
Adverse events
1
Recalls
62
Facilities

Description

The Stanbio Uri-Chek™ 10SG Urinalysis Reagent Strips are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes.

Recalls

DateFirmReason
2018-06-22Clarity Diagnostics LlcClarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Co

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.