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FastPack® IP System Image

FastPack® IP System

SEKISUI DIAGNOSTICS | Immunoassay Analyzers

The FastPack® IP System is a fully automated quantitative immunoassay analyzer designed for use in the Physician Office laboratory.

FastPack® IP System

FastPack® IP System The FastPack® IP System is a fully automated quantitative immunoassay analyzer designed for use in the Physician Office laboratory. Utilizing sophisticated chemiluminescence technology, the FastPack® IP System provides the capability to produce complex immunoassay results in 12 minutes or less. It is versatile and requires minimal space while offering a test menu that will make a clinical impact to patient care. Assays include Vitamin D, Testosterone, TSH, Free T4, PSA and hCG

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SEKISUI DIAGNOSTICS

SEKISUI DIAGNOSTICS Logo

4 Hartwell Place | Lexington | MA | 02421 | US

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 Image

OSOM® BVBLUE® Test

SEKISUI DIAGNOSTICS | Rapid Tests

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

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

SEKISUI DIAGNOSTICS Logo

4 Hartwell Place | Lexington | MA | 02421 | US

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 Image

OSOM® Card Pregnancy Test

SEKISUI DIAGNOSTICS | Rapid Tests

Easy-to-read black and white results. Cassette format, increased sensitivity 20mIU/mL for Urine. Fast results in 3 minutes.

OSOM® Card Pregnancy Test

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

SEKISUI DIAGNOSTICS Logo

4 Hartwell Place | Lexington | MA | 02421 | US

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 Image

OSOM® H. pylori Test

SEKISUI DIAGNOSTICS | Rapid Tests

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

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

SEKISUI DIAGNOSTICS Logo

4 Hartwell Place | Lexington | MA | 02421 | US

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 Image

OSOM® hCG Combo Test

SEKISUI DIAGNOSTICS | Rapid Tests

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

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

SEKISUI DIAGNOSTICS Logo

4 Hartwell Place | Lexington | MA | 02421 | US

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 Image

OSOM® hCG Urine Test

SEKISUI DIAGNOSTICS | Rapid Tests

Easy-to-read two color results. 25mIU/mL sensitivity; urine dipstick. Results in as little as one minute.

OSOM® hCG Urine Test

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

SEKISUI DIAGNOSTICS Logo

4 Hartwell Place | Lexington | MA | 02421 | US

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® iFOB Test Image

OSOM® iFOB Test

SEKISUI DIAGNOSTICS |

The CLIA-waived OSOM® iFOB test gives the physician and the patient a simpler, more compliant colon cancer screening option that is highly accurate and specific to human hemoglobin.

OSOM® iFOB Test

OSOM® iFOB Test
The OSOM iFOB Test is a rapid qualitative test for the immunochemical detection of fecal occult blood/human hemoglobin (hHb) in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders such as: diverticulitis, colitis, polyps, and colorectal cancer. Features and Benefits
  • Analytical sensitivity: 50 ng hHb/mL buffer or 50 µg hHb/g feces
  • Specific to human hemoglobin
  • Results in 5-10 minutes with less than 1 minute of hands on time
  • No dietary or drug restrictions
  • Easy to use patient sample collection procedure
  • CPT Code: G0328QW (Diagnosis) / 82274QW Screening
Description Catalog# Configuration Storage Shelf Life
OSOM® iFOB Test 1002 25-Test (plus 2 extra for external QC) Room Temperature 12 months
OSOM® iFOB Control Kit 1000 1-1mL Bottle Positive;1-1mL Bottle Negative Room Temperature 18 months
OSOM® iFOB Stool Collection Tubes 1001 25 Collection Tubes Room Temperature 12 months
OSOM® iFOB Patient Mailers 1003 25 Patient Mailers Room Temperature N/A
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SEKISUI DIAGNOSTICS

SEKISUI DIAGNOSTICS Logo

4 Hartwell Place | Lexington | MA | 02421 | US

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 Image

OSOM® Mono Test

SEKISUI DIAGNOSTICS | Rapid Tests

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

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

SEKISUI DIAGNOSTICS Logo

4 Hartwell Place | Lexington | MA | 02421 | US

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 Image

OSOM® Strep A

SEKISUI DIAGNOSTICS | Rapid Tests

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

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

SEKISUI DIAGNOSTICS Logo

4 Hartwell Place | Lexington | MA | 02421 | US

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® Trichomonas Test Image

OSOM® Trichomonas Test

SEKISUI DIAGNOSTICS | Rapid Tests

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

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

SEKISUI DIAGNOSTICS Logo

4 Hartwell Place | Lexington | MA | 02421 | US

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.