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.

CardioChek Glucose Test

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.

QC Sets and Panels: KWIK-STIK™ Blood Culture Identification 2 (BCID2) Verification Panel (Live Culture)

QC Sets and Panels: Helix Elite™ Gram-Negative Blood Culture Control Panel (Inactivated Pellet)

QC Sets and Panels: Helix Elite™ Enteric Pathogens Control Panel (Inactivated Pellet)

QC Sets and Panels: Helix Elite™ Respiratory Pathogens (16 Strains) Control Panel (Inactivated Pellet)

QC Sets and Panels: Helix Elite™ Blood Culture Identification (BCID) Verification Panel (Inactivated)

QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel (Inactivated Pellet)

QC Sets and Panels: Helix Elite™ Respiratory (21 Targets) Control Panel

QC Sets and Panels: Helix Elite™ Group A Streptococcus (GAS) Control Panel

QC Sets and Panels: Helix Elite™ C. difficile Control Panel (Inactivated Swab)

QC Sets and Panels: Helix Elite™ CT/GC/TV Control Panel (Inactivated Pellet)

QC Sets and Panels: Helix Elite™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

QC Sets and Panels: Helix Elite™ Enteric Parasite Control Panel (Inactivated Pellet)

QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)

QC Sets and Panels: Helix Elite™ Group B Streptococcus (GBS) Control Panel (Inactivated Swab)

QC Sets and Panels: Helix Elite™ Respiratory (4 Targets) Control Panel (Inactivated Swab)

QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)

QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)

QC Sets and Panels: Helix Elite™ Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet)

QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Negative Control (Inactivated Pellet)

QC Sets and Panels: Helix Elite™ Mycoplasma genitalium Control Panel (Inactivated Pellet)

QC Sets and Panels: Helix Elite™ Rapid Group B Streptococcus (GBS) Control Panel

QC Sets and Panels: KWIK-STIK™ Cdiff Verification Panel (Live Culture)

QC Sets and Panels: Helix Elite™ Pneumonia (33 Targets) Control Panel

QC Sets and Panels: Helix Elite™ Multiplex Vaginal Verification Panel

QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab)

QC Sets and Panels: Helix Elite™ Respiratory Control Panel (22 Targets)

QC Sets and Panels: Helix Elite™ Molecular Standards Bacterial vaginosis (BV) Control Panel

QC Sets and Panels: Helix Elite™ Molecular Standards Candida vaginitis/Trichomonas vaginalis (CV/TV) Control Panel

QC Sets and Panels: Helix Elite™ Molecular Standards Blood Culture Identification Control Panel (43 Targets)

QC Sets and Panels: Helix Elite™ Molecular Standards Multiplex Vaginal Control Panel

QC Sets and Panels: Helix Elite™ Rapid Group B Streptococcus (GBS) Verification Panel

QC Sets and Panels: Helix Elite™ SARS-CoV-2 Verification Panel

Data management reporting software use for Dexcom Continuous Glucose Monitoring devices.

Dexcom CLARITY software, web-based data management product is intendedfor use by both patients and healthcare professionals to assist people with diabetes in thereview, analysis and evaluation of historical CGM data to support effective diabetesmanagement. It is intended for use as an accessory to CGM devices with data interfacecapabilities.With RCP, it provides additional administrative features for use by Clinicians toaccess Dexcom CLARITY reports (digital or print) for their patients with diabetes. Thesefeatures do not change the intended use of CLARITY. They improve the usefulness of it fromthe clinician perspective.

Software-as-a-Service Diabetes Data Management Service. System extracts information from BGMs and formats reports of the blood glucose data.

t:connect Mobile Application, Mobile Bolus Enabled, 2.x (iOS)

t:connect Mobile Application, Mobile Bolus Enabled, 2.x (Android)