5-PLASMA Bivalirudin Control (5D-44905)
consists of lyophilized human plasmas spiked with defined concentrations of bivalirudin and is intended for use as quality control material for anti-IIa clotting and chromogenic assays for bivalirudin
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510k FDA Exempt For In Vitro Diagnostic Use Only.
5-PLASMA Bivalirudin Calibrator (5D-46905)
consists of lyophilized human plasma spiked with defined concentrations of bivalirudin and is intended to establish a calibration curve for use in anti-IIa clotting and chromogenic assays for bivalirduin
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510k FDA Exempt For In Vitro Diagnostic Use Only.
5-PLASMA Bivalirudin AMR Verification Kit
(5D-45905)
consists of lyophilized human plasmas spiked with defined concentrations of bivalirudin for verifying the Analytical Measurement Range (AMR) of anti-IIa clotting and chromogenic bivalirudin assay systems
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510k FDA Exempt For In Vitro Diagnostic Use Only.