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Coag-Sense, Inc.

48377 Fremont Blvd., Suite 113

Fremont, CA 94538

510-270-5442

 

General Information: info@coagusense.com or 1-866-903-0890

Technical Support: 1-866-903-0890 or techsupport@coagusense.com

www.coag-sense.com

COMPANY DESCRIPTION:

Based in Fremont, California, Coag-Sense was founded in 2008 to bring more accurate and robust anticoagulation monitoring technology to both clinicians and patients. The company's lead product
is the Coag-Sense PT/INR Monitoring System, which incorporates a novel direct micromechanical clot-detection technology.

This proprietary technology emulates the World Health Organization (WHO) gold standard tilt-tube method while requiring only a very small blood sample. Direct clot-detection technology provides
clinicians with the system reliability they demand and patients with the comfort of knowing that proper home testing can provide dependable results like a laboratory.

In 2016, CoaguSense was acquired by i-SENS, Inc.—a leader in point-of-care diagnostic technology and manufacturing.

PRODUCT DESCRIPTION:

The Coag-Sense is the world´s most precise portable PT/INR monitoring system ever. Unmatched clinical performance using direct mechanical clot detection.

This simplistic approach to PT/INR testing has delivered a stellar clinical performance history since its introduction.

Now you can get direct clot detection PT/INR technology in a convenient device with state-of-the-art features including Wi-Fi, Bluetooth®, Near Field Communication (NFC), and an easy to read color touchscreen.

PRODUCT FEATURES:

Cleared for home use: Yes, Patient self-testing (Prescription required)
Cleared for professional use: Yes, CLIA-Waived
Sampling size: 1 Drop (10 µL) capillary blood minimum
Sampling method: 21 g lancet; sample transfer tube

HOW TO USE THE COAG-SENSE PT/INR

STEP 1: Insert a test strip... STEP 2: Lance finger and collect bead of
blood with included transfer tube...
STEP 3: Dispense sample onto test strip... STEP 4: Wait for results - testing time is actual clotting time.

PRODUCT SPECIFICATIONS:

Specifications: Portable INR range: 0.8-8.0
Size: 5.9 in (150 mm) x 3.9 in (100 mm)
x 1.2 in (30 mm)		 Prothrombin time (PT): 8-80 seconds
Weight: 11.3 ounces (0.32 kg) ISi: ~1.0
Test strips: Individually pouched in boxed quantities Analysis time: <1 minute (Patients actual clotting time)
Storage: Non-refrigerated, up to 24 month shelf life QC: External using control strips containing plasma
Strip lot communication: Near Field Communication (NFC) chip QC and Operator Lockouts: Yes
Connectivity: Yes, Wired: Ethernet, USB Wireless: Wi-Fi, Bluetooth Memory: 2,000 Patient Test Results,
500 QC Test results
Barcode Scanning: Yes, Using optional USB or Bluetooth scanner Printing: Yes with optional bluetooth, USB or Wi-Fi printer
Connectivity interface: POCTl A/HL7 to LIS/HIS/Middelware Power Source: Built-in Lithium polymer rechargeable battery
Heparin sensitive: Yes, POC devices not recommended for bridging Operating Temperature: 65° F to 90° F (18° C to 32°)
Hematocrit range: 15-60% Warranty: 1 year with immediate replacement
Clot detection principle: Direct Micro-Mechanical