ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Fentanyl Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Levetiracetam II Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Tramadol Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Fentanyl II Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Hydrocodone Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK EDDP Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Voriconazole II Assay Test System

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Lacosamide Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Inherited Nucleotide Repeat Disorder Dna Test

FDA classification

FDA Class 2 ·Inherited Nucleotide Repeat Disorder Dna Test

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification

FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Next Generation Sequencing Based Tumor Profiling Test

FDA classification

FDA Class 2 ·Next Generation Sequencing Based Tumor Profiling Test

Dna And Rna Oncology Controls

FDA classification

FDA Class 2 ·Dna And Rna Oncology Controls

Complement 4d (C4d) And Complement Receptor 1 (Cr1)

FDA classification

FDA Class 2 ·Complement 4d (C4d) And Complement Receptor 1 (Cr1)

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

FDA classification

FDA Class 2 ·High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids