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Comment: The applicant commented that FDA first issued the VersaVue TM Single-Use Flexible Cystoscope 510(k) clearance in 2023, that the VersaVue TM Single-Use Flexible Cystoscope was not receiving payment as an outpatient service as of December 31, 1996, and that it is not described by any current or previous device categories

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Acute renal failure selective biomarker evaluation The proximal tubule apical membrane of injured rat kidneys expresses kidney injury molecule-1, a type-1 transmembrane protein that is ordinarily absent

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