The NEPHROCHECK Calibration Verification (Cal Vers) Materials are to verify calibration of the NEPHROCHECK Test System.

The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK Test System is intended to be used in patients 21 years of age or older.

The NEPHROCHECK Liquid Controls are used for the quality control monitoring of the NEPHROCHECK Test System.

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.Sunquest Laboratory is intended for use only by professionals who have received extensivetraining in the use of the software. Sunquest Laboratory is controlled via user defined securitylevels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including:• Patient registration• Order entry and order modification• Specimen collection, verification, suitability, and distribution• Quality assurance checking• Workload recording• Billing charge capture• Standards and controls recording• Test order result inquiry and reporting• Organism susceptibility and epidemiology records• Microbiology culture direct examination and observation recording• Outreach clients, specimens, and results• Client-specific reporting capabilities• Inbound client service request tracking• Historical data

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.Sunquest Laboratory is intended for use only by professionals who have received extensivetraining in the use of the software. Sunquest Laboratory is controlled via user defined securitylevels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including:• Patient registration• Order entry and order modification• Specimen collection, verification, suitability, and distribution• Quality assurance checking• Workload recording• Billing charge capture• Standards and controls recording• Test order result inquiry and reporting• Organism susceptibility and epidemiology records• Microbiology culture direct examination and observation recording• Outreach clients, specimens, and results• Client-specific reporting capabilities• Inbound client service request tracking• Historical data

Sunquest PowerPath supports anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information.

The intended use of Sunquest PowerPath is to support anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information.

Sunquest Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform.• Sunquest Physician Portal• Sunquest Advanced EMR Connectivity• Sunquest Patient Service Center (PSC) Portal• Sunquest Multi-Lab NetworkingThese solutions together represent a robust software solution set that enables diagnostic testing facilities to successfully support electronic ordering and/or result reporting with physician offices, nursing homes, patient service centers, reference labs, and other healthcare facilities.

Sunquest Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform.• Sunquest Physician Portal• Sunquest Advanced EMR Connectivity• Sunquest Patient Service Center (PSC) Portal• Sunquest Multi-Lab Networking

Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform.• Clinisys Physician Portal• Clinisys Advanced EMR Connectivity• Clinisys Patient Service Center (PSC) Portal• Clinisys Multi-Lab Networking

Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information.

Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information.

Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information.

Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information.

Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information.

Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information.

Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information.

Sunquest CoPathPlus supports anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information..

Sunquest Application Manager (SAM) supports laboratories in the management of laboratory workflow (order entry through reporting) and to transfer test results and information.

Sunquest CoPathPlus supports anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information..

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data

Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility including pipetting systems (poolers), automation software (a track system), blood testing instrumentation, and Laboratory Information Systems (LIS). Bloodstream Software also contains a user interface (UI) that allows users of Bloodstream Software to monitor the testing progress of donor samples in their lab, as well as allowing limited interaction in the testing process, such as modifying or canceling orders, or reviewing and approving results.

Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility including pipetting systems (poolers), automation software (a track system), blood testing instrumentation, and Laboratory Information Systems (LIS). Bloodstream Software also contains a user interface (UI) that allows users of Bloodstream Software to monitor the testing progress of donor samples in their lab, as well as allowing limited interaction in the testing process, such as modifying or canceling orders, or reviewing and approving results.

Bordetella Direct Test Cartridge

Stool Bacterial Pathogens Panel Cartridge with sample prep device.

Shiga Toxin Direct Test Cartridge with sample prep device.

Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.

Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.

Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.

Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum.

Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum.

Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum.

Cardiac STATus Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of Cardiac STATus tests.

Dialysate Sampling Port Kit

Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in microprocessor software. Three softkeys and the key are all you need to operate the luminometer. Menus and parameters for functions that are not automated, are selected via these softkeys. The display shows the menu items, the actionsperformed and the user prompts.The luminometer includes an internal reading device for chip cards. Measurement protocols are saved on this chip card. During this procedure the user is prompted step by step to place the required tubes into the instrument for measurement. This ensures a high level of automation and standardization of the measurement process.