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PointofCare.net

Nanogen
10398 Pacific Center Court
San Diego, CA 92121 

Phone number to find salesperson
or request Point of Care information:

1-888-35 HEART (43278) x212 in North America
1-416-621-3445 x 212 outside North America

General email for information request:
nanogenpoc@nanogen.com

http://www.nanogen.com/solutions/rapidtesting/


CORPORATE DESCRIPTION:

Nanogen’s technologies are uniquely bridging the gap between early-stage scientific research and actual clinical practice. We have developed a strong product and proprietary technology base in advanced diagnostic solutions for two of the fastest growing in vitro diagnostic (IVD) markets – molecular diagnostics and rapid point-of-care testing.  All of our products are designed to improve the role diagnostics plays in improving individual patient care by providing more specific DNA-based results or by moving the diagnostic capability and decision closer to the patient.  The company’s rapid tests for acute cardiac conditions, Cardiac STATus and StatusFirst, and drugs of abuse, Tox STATus, are sold to customers requiring rapid results at or near the point of treatment.


TEST KIT REQUIREMENTS
Test kit name:

CLIA Classification (Waived, Moderately complex):

Moderately complex

 

 

Analytes performed on this device:

Troponin I
Myoglobin
CK-MB

CPT Code associated with each analyte:

Troponin I- 84512
Myoglobin- 83874
CK-MB- 82553

Test methodology:

Qualitative immunoassay

Sample volume:

150 μL

Time to result:

15 minutes or less

Units in which the test is reported:

Positive or negative

Test kit name:

CLIA Classification (Waived, Moderately complex):

Moderately complex

Analytes performed on this device:

NT-proBNP

CPT Code associated with each analyte:

NT-proBNP- 83880

Test methodology:

Quantitative immunoassay measuring N-terminal proBrain natiuretic peptide (NT-proBNP)

Sample volume:

3 drops from pipette provided
Time to result:  

Units in which the test is reported

pg/mL

Test kit name:

CLIA Classification (Waived, Moderately complex):

Moderately complex

 

 

Analytes performed on this device:

Amphetamine, Barbiturates, Benzodiazepine, Cocaine, Methadone, Methamphetamine, Opiates, Phencyclidine, Propoxyphene, Tricyclic Antidepressants, Marijuana

Test methodology:

Qualitative immunoassay

Sample volume:

100μl

Time to result:

15 minutes or less

Units in which the test is reported:

Negative or positive
Instrument Name:
iLynx
Model Name: IL9001
CLIA Classification:  The FDA lists the I-Lynx as class I
Data transfer capability: Yes
Test Menu (Analytes that can be performed on instrument): Troponin I
CK-MB
myoglobin

CPT code for each analyte:

Tn I – 84512

Myoglobin – 83874

CK-MB - 82553

Test Methodology: immunochromatography
Units in which the test result is reported none

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