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Showing Products For: CLIA Waived

OSOM® H. pylori Test SEKISUI DIAGNOSTICS
Detects IgG antibodies to H. pylori in serum, plasma or whole blood. CLIA-waived for whole blood. 95.9% sensitivity. Result in 10 minutes or less. 18 month room temperature storage.



OSOM® H. pylori Test


For the qualitative detection of Helicobacter pylori antibodies in serum, plasma or whole blood as an aid in the diagnosis of H. pylori infection.

Features and Benefits
  • Results in 10 minutes or less
  • 95.9% sensitivity versus biopsy/histology
  • Serum, plasma or whole blood
  • Easy-to-read results
  • CPT Code: Whole blood 86318QW/Serum or Plasma 86677


Description Catalog# Configuration Storage Shelf Life
OSOM® H. pylori Test 175 25-Test Room Temperature 18 months
OSOM® H. pylori Control Kit 176 1-5mL Bottle Positive;1-5mL Bottle Negative Refrigeration 18 months


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SEKISUI DIAGNOSTICS 4 Hartwell Place | | Lexington | MA | For over 35 years Sekisui Diagnostics has been committed to providing innovative medical diagnostics to physicians and laboratories. We develop, manufacture, and supply billions of tests each year to the global healthcare market. Our product lines include clinical chemistry and coagulation systems and reagents, point-of-care molecular, rapid tests and immunoassay system as well as enzymes and specialty biochemicals.
Silaris SEKISUI DIAGNOSTICS
A molecular test utilizing polymerase chain reaction (PCR) technology providing accurate results for early diagnosis and proper management of influenza.


Silaris® Influenza A&B Test


The CLIA Waived Silaris® Influenza A&B Test is a molecular diagnostic test utilizing polymerase chain reaction (PCR) technology providing accurate results for early diagnosis and proper management of influenza.

Features and Benefits
  • Accurate Molecular PCR Results
    • Influenza A: Sensitivity 97% & Specificity 94%
    • Influenza B: Sensitivity 94% & Specificity 99%
  • Affordable
    • Definitive diagnosis (no confirmation required)
    • Controls included with each kit
  • SIMPLE
    • Simple three step procedure and minimal hands on time of <1 minute
    • No refrigeration required


Description Catalog# Configuration Storage Shelf Life
Silaris®Influenza A&B Test 1027 25 Test Room Temperature 18 months
Silaris®Influenza A&B Control Kit 1024 5 - A+/B- Control Swabs;5- A-/B+ Control Swabs Room Temperature 18 months
Silaris®Influenza A&B Starter Pack 1028 50 Tests;1 – Silaris Dock Room Temperature
Silaris®Dock 1026 1 - Dock Room Temperature 3000 Tests


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SEKISUI DIAGNOSTICS 4 Hartwell Place | | Lexington | MA | For over 35 years Sekisui Diagnostics has been committed to providing innovative medical diagnostics to physicians and laboratories. We develop, manufacture, and supply billions of tests each year to the global healthcare market. Our product lines include clinical chemistry and coagulation systems and reagents, point-of-care molecular, rapid tests and immunoassay system as well as enzymes and specialty biochemicals.
Alere Cholestech LDX® Analyzer ABBOTT RAPID DIAGNOSTICS
The CLIA-waived Alere Cholestech LDX® Analyzer is engineered for confidence, providing accurate, actionable, and readily accessible results that have set the standard in point-of-care lipid profile, cholesterol, and glucose testing.


Alere Cholestech LDX® Analyzer


Accurate, actionable results from the leader in point-of-care lipid testing.

The CLIA-waived Alere Cholestech LDX® Analyzer is engineered for confidence, providing accurate, actionable, and readily accessible results that have set the standard in point-of-care lipid profile, cholesterol, and glucose testing.

Test fasting lipid profile: total cholesterol (TC), HDL & LDL cholesterol, and triglycerides (TRG) for risk assessment and lipid management. The Alere Cholestech LDX® System provides lab accurate results in just five minutes from a small fingerstick sample.

Benefits of the Alere Cholestech LDX® Analyzer:
  • CLIA-waived – no special training required
  • Rapid results – enables face-to-face counseling with patients
  • Fingerstick sampling – less painful and time consuming
  • Small sample size (40 µL) – easy to obtain
  • Lab accurate results
  • Improved office efficiencies – eliminates costly call backs to labs and patients

Simple 3-Step Testing:
Testing full lipid profile and glucose is as easy as 1, 2, 3:
  1. Perform a fingerstick and collect the sample with a capillary tube within 10 seconds.
  2. Dispense the sample into the test cassette.
  3. Insert the cassette and press the RUN button.


Relevant Clinical Areas:
  1. Family practices
  2. Internal medicine practices
  3. Pediatric practices
  4. Urgent care centers
  5. Cardiology practices
  6. Endocrinology practices
  7. Community health centers
  8. Hospital wellness programs


Alere LDX Alere LDX

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ABBOTT RAPID DIAGNOSTICS xxxx my street | | concord | NH | Abbott is a world leader in rapid diagnostics at the point of care, with a focus on cardio metabolic disease, infectious disease and toxicology.
Afinion™ 2 Analyzer ABBOTT RAPID DIAGNOSTICS
The Afinion™ 2 analyzer is a compact, rapid, multi-assay analyzer that provides valuable near patient testing at the point-of-care.


Afinion 2
Simply More Efficient.

Improve the way you monitor and manage your patients


The Afinion 2 analyzer is a compact, rapid, multi-assay analyzer that provides valuable near patient testing at the point-of-care.

With the Afinion System, there's no need to send test results to the lab or spend time tracking them down. That way you can keep your focus where it belongs – on the patient.

Benefits of the Afinion 2 Analyzer:
Multiple analytes on one instrument
  • The Afinion 2 analyzer makes it fast and easy to test quantitative determinations of HbA1c and ACR.
  • HbA1c test is CLIA Waived
Short assay times
  • HbA1c results in 3 minutes
  • ACR results in 5 minutes
Multiple sample types
  • The analyzer is designed to enable simple and fast on-the-spot testing, regardless of the sample type, which may be whole blood or urine, and to deliver accurate results during patient consultation for improved patient management.
Connected
  • The Afinion 2 analyzer can reliably transfer test information to a HIS or LIS system. The Afinion 2 Analyzer automatically transfers patient and control results via TCP/IP networking using the protocols POCT1-A, HL7, ASTM 1381-85 (low level) or ASTM 1394-97 (high level), selectable by configuration.
All-in-one test cartridge
  • The analyzer and Test Cartridges have been precision engineered with each test cartridge containing an integrated sample collection device and all necessary reagents for a single test.
Automatic self-check system
  • The Afinion 2 analyzer eliminates erroneous results with integrated error detection and self-check systems.
No additional calibration necessary
  • Each Afinion 2 analyzer has a fixed factory calibration. Each lot of an Afinion test includes calibration data stored in the barcode label. The lot calibration data is read by the integrated camera and used for calculating results.


3-Step Procedure
  1. Collect the sample with the integrated sampling device.
  2. Place the sampling device back in the test cartridge.
  3. Place the test cartridge in the analyzer and close the lid. The processing starts automatically


Afinino2 ACR Procedure Afinion 2 Alere LDX

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ABBOTT RAPID DIAGNOSTICS xxxx my street | | concord | NH | Abbott is a world leader in rapid diagnostics at the point of care, with a focus on cardio metabolic disease, infectious disease and toxicology.
CoaguChek XS Plus ROCHE DIAGNOSTICS
Smart PT/INR monitoring at the physician's practice. Healthcare professionals can measure a patient's PT/INR value usually in less than 1 minute with a drop of capillary blood (8 µl).


CoaguChek® XS Plus

Simplified testing with enhanced connectivity for professional use
This small, battery-powered, handheld meter is portable and efficient, ideal for mid to high-volume clinical settings. Plus, you can test and treat in one appointment, using the fingerstick test that patients prefer.

Accurate
  • 97% accuracy to lab for confidence in results*
  • Only handheld, CLIA-waived PT/INR monitoring system that neutralizes therapeutic levels of heparin and low molecular weight heparin within a specified range. See package insert for more information.
  • INR corrected for wide range of hematocrit
  • Two levels of built-in, onboard controls within the test chamber — no external QC necessary


Easy to use
  • Test results in about 1 minute with a small 8 µl sample
  • Large top- and side-dosing area enables easy sample application
  • Outside meter blood application — minimizes potential for cross-contamination
  • Calibration information is provided by a code chip included in all strip vials – no manual calibration, pipetting or preparation of reagents are needed.
  • Up to 21-month strip shelf life from date of manufacture — no refrigeration needed
  • Icon-driven, color touchscreen interface


Smart
  • Stores 2,000 patient and 500 optional liquid QC results
  • Ability to denote patient ID in several fields and add comments after results
  • Data storage for up to 60 code chips
  • Bidirectional data transfer with Roche cobas® IT1000 and other industry leading connectivity systems
  • Operator and QC lockout capabilities


*97% correlation with lab results using Dade Innovin reagent on a Sysmex 560 Analyzer. See package insert for more information. CoaguChek XS PT Test [package insert 05967694001(03)]. Indianapolis, Ind.: Roche Diagnostics; 2013

ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways
CoaguChek® XS ROCHE DIAGNOSTICS
Only handheld, CLIA-waived PT/INR monitoring system that neutralizes therapeutic levels of heparin and low molecular weight heparin within a specified range


CoaguChek® XS Meter

Accurate
  • 97% accuracy to lab for confidence in results*
  • Only handheld, CLIA-waived PT/INR monitoring system that neutralizes therapeutic levels of heparin and low molecular weight heparin within a specified range. See package insert for more information.
  • Two levels of built-in, onboard controls within the test chamber


Easy to use
  • Test results in about one minute with a small 8 µl sample
  • Large top- and side-dosing area enables easy sample application
  • Outside meter blood application — minimizes potential for cross-contamination
  • Up to 21-month strip shelf life from date of manufacture — no refrigeration needed


*97% correlation with lab results using Dade Innovin reagent on a Sysmex 560 Analyzer. See package insert for more information. CoaguChek XS PT Test [package insert 05967694001(03)]. Indianopolis, IND.: Roche Diagnostics; 2013

ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways
cobas® Influenza A/B assay ROCHE DIAGNOSTICS
The cobas Influenza A/B assay is the first CLIA-waived, real-time PCR test to detect Influenza A and B in ~20 minutes


cobas® Influenza A/B assay

The cobas® Influenza A/B assay is the first CLIA-waived, real-time PCR test to detect Influenza A and B in ~20 minutes. Available for use in non-traditional testing sites, including ERs, physician offices, pharmacy clinics and other urgent care settings.

Benefits:
  • Lab-quality performance in the detection and differentiation of Influenza A and Influenza B
  • Fast results—20-min. turnaround time
  • Simplicity—minimal hands-on time, walk-away test with easy results interpretation
  • Supports timely, confident treatment decisions


ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways
cobas® Strep A assay ROCHE DIAGNOSTICS
The cobas Strep A assay is a CLIA-waived, real-time PCR test for the detection of Streptococcus group A in throat swab specimens from patients with signs and symptoms of pharyngitis.


cobas® Strep A assay

The cobas® Strep A assay is a CLIA-waived, real-time PCR test for the detection of Streptococcus group A in throat swab specimens from patients with signs and symptoms of pharyngitis. With excellent sensitivity and specificity, this assay provides the reassurance needed when deciding whether or not to treat with antibiotics.

Benefits:
  • Extraordinary performance in the detection of Streptococcus pyogenes (Group A Strep)
  • Fast results, 15-min. turnaround time
  • Ease of use—minimal hands-on-time, objective, unambiguous results
  • No confirmation require at time of visit for confident treatment decisions


ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways
cobas® Influenza A/B & RSV assay ROCHE DIAGNOSTICS
The cobas Influenza A/B & RSV assay is the first CLIA-waived, real-time PCR test that differentiates Influenza A, Influenza B and RSV in 20 minutes


cobas® Influenza A/B & RSV assay

The cobas Influenza A/B & RSV assay is the first CLIA-waived, real-time PCR test that differentiates Influenza A, Influenza B and RSV in 20 minutes. It's available for use in hospitals, physician offices and urgent care settings.

Benefits:
  • Lab-quality performance in the detection and differentiation of Influenza A, Influenza B and RSV strains
  • Fast results, 20-min. turnaround time
  • Simplicity—minimal hands-on time, walkaway test with easy results interpretation
  • Supports timely, confident treatment decisions


ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways
BTA stat Test POLYMEDCO, INC.
The BTA stat Test is an in vitro immunoassay intended for the qualitative detection of bladder tumor antigen in urine of persons diagnosed with bladder cancer. This test is indicated for use as an aid in the management of bladder cancer patients in conjunction with cytology.

 The BTA stat® test is a point of care technology for the early detection of recurrent bladder cancer. This method uses monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine.  It is a single-step, rapid immunochromatographic assay for bladder tumor-associated antigen in voided urine.  The specificity of the BTA stat® test was 93 - 95% in patients with non-genitourinary diseases and cancers and healthy individuals tested as part of a multi-center study.  The test has a sensitivity that is considerably higher than voided urine cytology, enabling detection of recurrent early stage and grade cancers that cytology often misses.  Requiring three drops of urine, the result is delivered in only five minutes.  The appearance of a line in the patient window indicates a positive result.  The BTA stat® test requires one voided urine sample with no sample preparation.  The BTA stat® test is CLIA waived and also available for prescription home use.

POLYMEDCO, INC. 510 Furnace Dock Road | | Cortlandt Manor | NY | Polymedco Inc. is a leading manufacturer, marketer, and distributer in the clinical laboratory marketplace. Polymedco supplies clinical diagnostic test kits and devices that are specialized in chemistry, hematology and cancer.