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Clinical Chemistry

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Name
Company Name
Description
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cobas® MRSA/SA Test
Roche Molecular Systems, Inc.
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cobas® MRSA/SA Test
Roche Molecular Systems, Inc.
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cobas® 4800 CT/NG Test
Roche Molecular Systems, Inc.
0
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cobas® 4800 CT/NG Test
Roche Molecular Systems, Inc.
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cobas® 4800 System Control Diluent Kit
Roche Molecular Systems, Inc.
0
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LightCycler® Advanced Lysis
Roche Molecular Systems, Inc.
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LightCycler® MRSA Advanced Test
Roche Molecular Systems, Inc.
0
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cobas® PCR Female Swab Sample Kit
Roche Molecular Systems, Inc.
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cobas® PCR Urine Sample Kit
Roche Molecular Systems, Inc.
0
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Greater Goods Essential
i-SENS, Inc.
Greater Goods Essential Blood Glucose Monitoring System
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Greater Goods Essential
i-SENS, Inc.
Greater Goods Essential Blood Glucose Test Strip
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Greater Goods
Greater Goods
0030 Omada BGM- RPM
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Tri-Tech Forensics, Inc.
TRI-TECH FORENSICS, INC.
Blood Alcohol Kit for the state of Colorado
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Tri-Tech Forensics, Inc.
TRI-TECH FORENSICS, INC.
Tri-Tech Forensics Custom Sexual Assault Kit
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Tri-Tech Forensics, Inc.
TRI-TECH FORENSICS, INC.
Tri-Tech Forensics Custom Blood and Urine Specimen Collection Kit
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Tri-Tech Forensics, Inc.
TRI-TECH FORENSICS, INC.
Tri-Tech Forensics Custom Blood Alcohol Kit
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Tri-Tech Forensics, Inc.
TRI-TECH FORENSICS, INC.
10 ml Grey Stoppered Blood Tube, Each
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The Babydust Method
BABYDUST METHOD LLC, THE
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The Babydust Method
BABYDUST METHOD LLC, THE
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Evidence Pregnancy Test
VEDALAB
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GenUltimate!
PHARMA TECH SOLUTIONS, INC.
Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters.
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Rosie SmartMeter Test Strips 50ct(vial)
HMD BIOMEDICAL INC.
Rosie SmartMeter Blood Glucose GDH-FAD Test Strips
0
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Rosie SmartMeter Glucose Control Solutions
HMD BIOMEDICAL INC.
Rosie SmartMeter glucose control solution
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Rosie SmartMeter Professional Strip
HMD BIOMEDICAL INC.
Rosie SmartMeter Professional Strip-Foil
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Rosie SmartMeter NFC Professional
HMD BIOMEDICAL INC.
Rosie SmartMeter NFC Professional Blood Glucose Meter
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xReader System
ESCREEN, INC.
The xReader System consists of a small, portable high resolution flatbed scanner, customized Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The xReader System is intended for use with the xCup, which is a rapid, single use, disposable immunochromatographic test for the qualitative detection of drugs of abuse in human urine.The xReader System detects drug classes at the following cutoff concentrations: Amphetamines at 500 ng/mL; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL. Configurations of the xCup may consist of any combination of the listed drug analytes.The xCup test devices are run in the xReader System according to their specific instructions for use. At the conclusion of the test an image is captured and the Software determines whether the colored test lines for each analyte are above or below the threshold associated with a Send to Lab or a Discard result. The Software also confirms the validity of the results by verifying the presence of control lines and analyzing the specimen validity. The xReader System is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by minimally trained users. The test is not intended for over-the-counter use. The xCup test devices cannot be read visually.
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BGM GALECTIN-3
BG MEDICINE, INC.
Galectin-3 In Vitro Diagnostic Assay
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GenUltimate!
PHARMA TECH SOLUTIONS, INC.
Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters
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Procleix Xpress® System
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
The Procleix Xpress System v3.2 (Software and Instrument) is intended to be used to create whole blood lysates and pools of whole blood lysate for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
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Procleix Xpress® System
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
The Procleix Xpress® System v2.0 (Software and instrument) is intended to be used to create whole blood lysates and pools of whole blood lysates for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition.
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Bruno
BRUNO PHARMA INNOVATIONS, LLC
Ketone Test Strips
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Bruno
BRUNO PHARMA INNOVATIONS, LLC
Blood Glucose Test Strips
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Bruno
BRUNO PHARMA INNOVATIONS, LLC
Multi-Functional Monitoring System
0
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Preview Pregnancy Test
WONDFO USA CO., LTD.
3-Midstreams; hCG Pregnancy Midstream Test Retail Box 3 Pcs
0
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Preview Pregnancy Test
WONDFO USA CO., LTD.
2-Midstreams; hCG Pregnancy Midstream Test Retail Box 2 Pcs
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SurePredict(R)
Ushealthtest
HCG Strip Test
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dBest
AMERITEK, INC.
0
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Expanse Laboratory/Genetics/Microbiology/Anatomical Pathology
MEDICAL INFORMATION TECHNOLOGY, INC.
MEDITECH's Laboratory application closely integrates requisition, specimen processing, and patient information with data in Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient collection of specimens, and result entry through seamless integration with laboratory instruments. Authorized users have the ability to view laboratory results via a specimen inquiry or a patient summary. MEDITECH's Genetics application closely integrates requisition, specimen processing, and patient information with data in an Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient collection of specimens, and result entry. Authorized users have the ability to view genetic test results via a specimen inquiry or a patient summary.MEDITECH's Microbiology application closely integrates requisition, specimen processing, and patient information with data in the Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient processing for collection and resulting of specimens including: bacteriology, mycology, parasitology, virology, and mycobacteriology. MEDITECH's Anatomical Pathology application automates the data handling needs of the Pathology department with features for recording, storing, coding, searching, and reporting Pathology cases. MEDITECH's EHR gives users the ability to view Radiology reports and lab results pertinent to the case, and to integrate relevant data into Pathology reports. Authorized users have the ability to view Anatomic Pathology results from within the network.
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Scan
LEXINGTON WELLNESS HOLDINGS INC.
Blood glucose meter.
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OneDraw A1C Test System
Drawbridge Health, Inc.
The OneDraw™ A1C Test System is a single-use, sterile, capillary blood specimen collection, stabilization, and transportation system. The device incorporates lancets to make two small incisions in the skin and a vacuum to draw blood at the surface of the skin and through channels to deposit the blood onto collection and stabilization matrices. The collection kit is designed to facilitate in vitro laboratory testing of blood samples for clinical chemistry assays. OneDraw™ includes a collection device, transport sleeve, accessories, and instructions needed to collect, package, and mail the sample collection cartridge to the certified clinical laboratory for HbA1c testing.
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BG Analytics Software
ASSOCIATES OF CAPE COD, INC.
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.
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Torq
MEDTOX DIAGNOSTICS, INC.
Torq ZDrive MR, Ram Scientific
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Torq
MEDTOX DIAGNOSTICS, INC.
Torq MiniDrive2
0
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Torq
MEDTOX DIAGNOSTICS, INC.
Torq ZDrive MR, BD Microtainer
0
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Polytel GMA
Polymap Wireless
Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Abbott. Specific meters supported are FreeStyle Lite and FreeStyle Freedom Lite
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Polytel GMA
Polymap Wireless
Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Bayer. Specific meters supported are Breeze2, Contour, Contour TS, Contour next EZ.
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Polytel GMA
Polymap Wireless
Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by LifeScan Inc. Specific meters supported are OneTouch Ultra, OneTouch Ultra2, OneTouch UltraMini, OneTouch UltraEasy
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RightSpotpH®
RIGHTBIO/METRICS INC.
Small Bore Indicator
0
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α-spot
EASTERN BUSINESS FORMS INC
LFP Alpha-Spot Kit
0
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903™
EASTERN BUSINESS FORMS INC
903 Filter Paper