Product Classification / EMDN Category
FDA Product Code: NWM
Directory of devices assigned to product classification code NWM.
gudid
The ARK Pregabalin II Assay is an immunoassay intended for the qualitative and /or semi-quantitative determination of pregabalin in human urine at a cutoff concentration of 500 ng/mL.
Manufacturer: ARK DIAGNOSTICS INC
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gudid
The ARK Pregabalin II Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of pregabalin in human urine at a cutoff concentration of500 ng/mL.
Manufacturer: ARK DIAGNOSTICS INC
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gudid
The ARK Pregabalin Urine Assay is a homogeneous enzyme immunoassay intended for the quantitative and/or semi-quantitative analysis of pregabalin in human urine.
Manufacturer: ARK DIAGNOSTICS INC
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gudid
The ARK Topiramate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.
Manufacturer: ARK DIAGNOSTICS INC
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