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OSOM® Trichomonas Test SEKISUI DIAGNOSTICS
The only CLIA-waived rapid test for Trichomonas. Detects the antigen so no hurrying to the microscope to see motile organisms. More sensitive than wet mount. Results in 10 minutes or less.


OSOM® Trichomonas Test

The OSOM® Trichomonas Test is intended for the qualitative detection of Trichomonas vaginalis (“Trichomonas”) antigens from vaginal swabs or from the saline solution prepared when making wet mounts from vaginal swabs.

Features and Benefits
  • The only CLIA-waived rapid test for the detection of Trichomoniasis
  • 95% agreement with culture and wet mount combined
  • Detects the antigen; does not require live organism
  • Results in 10 minutes or less
  • Objective easy-to-read two-color results
  • Controls included in the kit


Description Catalog# Configuration Storage Shelf Life
OSOM® Trichomonas Test 181 25-Test Room Temperature 16 months
OSOM® Trichomonas Control Kit 182 10 Positive Swabs Room Temperature 19 months
OSOM® Vaginitis Transport Set (for use with OSOM® Trichomonas and OSOM® BVBlue) 185 Room Temperature


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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.
OSOM® Ultra Strep A SEKISUI DIAGNOSTICS
Clear, accurate results in minutes can help everyone feel better before the office visit is over.VERY ACCURATE – 96% sensitivity; 98% specificity.FAST- Results in 5 minutes.EASY-TO-READ – Two-color results.CONVENIENT – Compact packaging. Available in 25 or 50 tests. Kit Includes positive and negative controls. 50 Test Kit includes 2 additional test sticks to run QC.


OSOM® Ultra Strep A Test

A color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens.

Features and Benefits
  • Easy-to-read two-color results
  • Not statistically different than single swab culture (refer to instructions for use)
  • Results in 5 minutes
  • CPT Code: 87880QW


Description Catalog# Configuration Storage Shelf Life
OSOM® Ultra Strep A Test 149 50 Test (plus 2 extra for external QC) Room Temperature 15 months
OSOM® Ultra Strep A Test 147 25 Tests Room Temperature 15 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.
OSOM® Card Pregnancy Test SEKISUI DIAGNOSTICS
Easy-to-read black and white results. Cassette format, increased sensitivity 20mIU/mL for Urine. Fast results in 3 minutes.


OSOM® hCG Card Pregnancy Test

A rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an aid in the early determination of pregnancy.

Features and Benefits
  • Increased sensitivity: 20mIU/mL
  • Fast - results in 3 minutes
  • Easy-to-read black on white results
  • 24-month room temperature storage
  • CPT Code: 81025QW


Description Catalog# Configuration Storage Shelf Life
OSOM® hCG Card Pregnancy Test 102 25-Test Room Temperature 24 months
OSOM® hCG Urine Control Kit 134 1-10mL Bottle Positive;1-10mL Bottle Negative Refrigeration 15 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.
OSOM® hCG Urine Test SEKISUI DIAGNOSTICS
Easy-to-read two color results. 25mIU/mL sensitivity; urine dipstick. Results in as little as one minute.


OSOM® hCG Urine Test

For the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.

Features and Benefits
  • Economical
  • Easy-to-read two-color results
  • 25mIU/mL sensitivity
  • Results in 5 minutes or less
  • CPT Code: 81025


Description Catalog# Configuration Storage Shelf Life
OSOM® hCG Urine Test 101 50-Test Room Temperature 24 months
OSOM® hCG Urine Control Kit 134 10 Positive Swabs1-10mL Bottle Positive;1-10mL Bottle Negative Refrigeration 15 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.
OSOM® Mono Test SEKISUI DIAGNOSTICS
Detects heterophile antibodies to EBV (monocucleosis) in serum, plasma, or whole blood. Easy-to-read two color results. 100% sensitivity, 99% specificity. No age restriction. Result in five minutes or less. Room temperature storage.


OSOM® Mono Test

For the qualitative detection of infectious mononucleosis heterophilic antibodies in serum, plasma or whole blood.

Features and Benefits
  • Results in 5 minutes
  • > 99% Sensitivity; 96% specificity
  • No age limitation
  • Easy-to-read two-color results
  • Serum, plasma or whole blood
  • CPT Code: Whole blood 86308QW / Serum or plasma 86308


Description Catalog# Configuration Storage Shelf Life
OSOM® Mono Test 145 25 Tests (plus 2 extra for external QC) Room Temperature 12 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.
OSOM® BVBLUE® Test SEKISUI DIAGNOSTICS
The OSOM BVBLUE Test detects elevated vaginal fluid sialidase, an enzyme produced by pathogens associated with Bacterial Vaginosis including Gardnerella, Bacteroides, Prevotella and Mobilincus. CLIA-waived objective results in 10 minutes.


OSOM® BVBLUE® Test

Detects elevated vaginal fluid sialidase activity, an enzyme produced by bacterial pathogens associated with bacterial vaginosis including Gardnerella, Bacteroides, Prevotella and Mobiluncus.

Features and Benefits
  • CLIA-Waived
  • 92.8% sensitive, 98% specific versus Gram Stain
  • 1-minute hands-on-time; 10 minute read time
  • Instant color change provides clear easy-to-read results.
  • CPT Code: 87905QW


Description Catalog# Configuration Storage Shelf Life
OSOM® BVBLUE® Test 183 25-Test (plus 2 extra for external QC) Refrigerated 11 months
OSOM® BVBLUE® Controls (sold separately) 184 1-5mL Bottle Positive,1-5mL Bottle Negative Refrigerated 12 months
OSOM® BVBLUE® Transport Swabs 186 Room Temperature
OSOM® Vaginitis Transport Set (for use with OSOM® Trichomonas and OSOM® BVBlue) 185 Room Temperature


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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.
OSOM® hCG Combo Test SEKISUI DIAGNOSTICS
Easy-to-read black and white results. For use with Urine or Serum. Cassette format. Detects hCG at 20mIU/mL in 3 minutes for Urine and 10mIU/mL in 5 minutes for Serum.


OSOM® hCG Combo Test

A rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy.

Features and Benefits
  • Sensitivity: 10 mIU/mL Serum or 20 mIU/mL Urine
  • Easy-to-read black on white results
  • Fast - 3 minutes for urine; 5 minutes for serum
  • 24-month shelf life
  • Room temperature storage
  • CPT Code: Urine – 81025QW/Serum – 84703


Description Catalog# Configuration Storage Shelf Life
OSOM® hCG Combo Test 124 25-Test Room Temperature 24 months
OSOM® hCG Urine Control Kit 134 1-10mL Bottle Positive;1-10mL Bottle Negative Refrigeration 15 months
OSOM® hCG Serum Control Kit 138 1-5mL Bottle Positive;1-5mL Bottle Negative Refrigeration 12 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.
OSOM® Strep A SEKISUI DIAGNOSTICS
Clear, accurate results in 5 minutes or less. Easy-to-read two color results - 50 Tests - Includes 2 additional tests for external QC. Room temperature storage - Controls included in kit.


OSOM® Strep A Test

A color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens.

Features and Benefits
  • Easy-to-read two-color results
  • 96% sensitivity; 98% specificity versus culture
  • Results in 5 minutes
  • CPT Code: 87880QW


Description Catalog# Configuration Storage Shelf Life
OSOM® Strep A Test 141 25-Test (plus 2 extra for external QC) Room Temperature 17 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.
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.