Vital Diagnostics, Inc.
27 Wellington Road
Lincoln, RI 02865
1-800-345-2822
www.vitaldiagnostics.com
uscustserv@vitaldiagnostics.com |
www.vitaldiagnostics.com
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Corporate Description:
Vital Diagnostics provides products and services
for the clinical laboratory in the traditional in-vitro
diagnostics market worldwide, with a focus on the
physician’s office, hospital and small-to-medium sized
laboratory segments.
Vital Diagnostics manufacturers and distributes clinical
chemistry, hematology and immunoassay analyzers, along
with reagents, designed to save the laboratory time and
money. Every product manufactured meets or exceeds
regulatory guidelines; the company is ISO 13485:2003 and
ISO 9001:2008 certified. With customers in approximately
100 countries, Vital Diagnostics has achieved a leading
market share for instruments and reagents sold into
moderately complex laboratories.
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Products:
Test Kits I
Instruments I
Software |
Test Kits |
Pathfast
Troponin I |
Pathfast
CK-MB |
Pathfast
NTproBNP |
Pathfast
Myoglobin |
Pathfast
hsCRP |
Pathfast
D-Dimer |
CLIA
Classification |
Moderately
complex |
Moderately
complex |
Moderately
complex |
Moderately
complex |
Moderately
complex |
Moderately
complex |
Analytes |
Troponin
I |
CK-MB |
NTproBNP |
Myoglobin |
hsCRP |
D-Dimer |
CPT Code |
84484 |
82553 |
83880 |
83874 |
86141 |
85379 |
Test
Methodology |
chemi-luminescence |
chemi-luminescence |
chemi-luminescence |
chemi-luminescence |
chemi-luminescence |
chemi-luminescence |
Sample volume |
100 µL |
100 µL |
100 µL |
100 µL |
100 µL |
100 µL |
Time to
result |
17 minutes |
17 minutes |
17 minutes |
17 minutes |
17 minutes |
17 minutes |
Units
|
ng/mL |
ng/mL |
pg/mL |
ng/mL |
mg/L |
µg/mL FEU |
MSDS |
Click here |
Click here |
Click here |
Click here |
Click here |
Click here |
|
Instruments |
Pathfast
CLEIA |
Features |
-
Results in 17 minutes
-
Direct measurement from whole blood samples
-
6 parallel channels allows either 6 samples
or 6 tests for one sample to be run
simultaneously
-
99th percentile, guideline
acceptable Troponin I results available at
point-of-care
|
|
CLIA |
Moderately
complex |
Size/Weight |
375x570x510mm |
Data Transfer |
Yes |
Test Menu/
CPT Code/
Units
|
• |
Troponin I |
84484 |
ng/mL |
• |
CK-MB |
82553 |
ng/mL |
• |
NTproBNP |
83880 |
pg/mL |
• |
Myoglobin |
83874 |
ng/mL |
• |
hsCRP |
86141 |
mg/L |
• |
D-Dimer |
85379 |
µg/mL
FEU |
|
Test
Methodology |
Chemiluminescence |
|
Software |
Embedded within Instrument |
Description |
The Pathfast offers a combination of lock
out features for users, calibration, QC and
cartridge expiration. User IDs are password
protected, giving piece of mind that
unauthorized users cannot operate the
system. The settings are user defined.
|
User
Features |
The system is easy and intuitive to operate.
To run patient samples, just follow three
simple steps. First, add the sample to the
reagent cartridge. The Pathfast requires
only 100 uL of sample for each test. Second,
insert the cartridge rack into the Analyzer.
Third, shut the door and press start. The
Pathfast takes care of everything else
automatically |
QC
Features |
The Pathfast also provides a lockout feature
for calibration, QC, and cartridge
expiration. Tests cannot be reported due to
expired quality control, quality control
failures, calibration frequency, and reagent
expiration. |
Inventory Control |
Barcoded reagent strips ensure that expired
reagents cannot be run. |
Install Base |
Several research facilities. No clinical
sites to date. |
Exporting |
LIS |
LIS
Interface |
ASTM |
Screens |
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Last updated: 09/17/2012
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Questions or corrections: editor@pointofcare.net.
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