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Alfa
Scientific Designs
13200 Gregg Street
Poway, CA 92064-6802 USA
Tel: (858) 513-3888 | Fax:
(858) 513-8388
Toll Free (U.S. only): (877) 204-5071
info@alfascientific.com |
https://www.alfascientific.com
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CORPORATE
DESCRIPTION: |
Alfa Scientific Designs, Inc.
(ALFA), established in 1996, is a
creative leader innovating new
products for rapid, point-of-care
medical devices. For the past 20
years, ALFA has developed and
manufactured rapid tests, all made
exclusively in the USA. With more
than 50 products that are US FDA
510(k) cleared (for professional and
OTC use) and CLIA waived, ALFA also
offers a broad range of services
including contract product
development, technology transfer,
OEM services, custom assembly, and
private labeling.
In 2016 ALFA added its most
significant invention to its broad
range of outstanding products and
services, Driven Flow™ Technology.
ALFA continues to demonstrate
innovative leadership with the
addition of another invention to its
extensive patent portfolio. With a
revolutionary design that
significantly improves the speed and
accuracy of rapid POC tests, Driven
Flow™ is a groundbreaking
technology and ALFA is premiering
its first featured product with the
One-Minute Instant-view®
iFOB device.
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PRODUCT DESCRIPTIONS: |
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 |
Instant-View Fecal Occult
Blood Test (Cassette) |
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CLIA
Classification |
Waived |
|
CPT
Code |
82274 |
|
Test
methodology |
Lateral Flow Immunoassay |
|
Sample volume |
4
drop |
|
Time
to result |
5-10
min. |
|
Units
in which the test is reported |
Available in box of 20 |
|
Other
|
-
Sensitivity 50 ng hHb/ml buffer or 50 mg hHb/g feces
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Accuracy 98%
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Self contained collection device
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No food or medicine restrictions
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Detects human hemoglobin only
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24 months of shelf life
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Product Code(s) |
05-7602 |
|
 |
Instant-View H.
pylori Rapid Test |
|
CLIA
Classification |
Waived |
|
CPT
Code |
86318 |
|
Test
methodology |
Lateral Flow Immunoassay |
|
Sample volume |
1
drop or 50 µl |
|
Time
to result |
4-7
min. |
|
Units
in which the test is reported |
Available in box of 25 |
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Other
|
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|
Product Code(s) |
05-9475 |
|
 |
Instant-View
Troponin I Whole Blood/Serum Test
(Cassette) |
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CLIA
Classification |
Moderate |
|
CPT
Code |
84512 |
|
Test
methodology |
Lateral Flow Immunoassay |
|
Sample volume |
4
drops |
|
Time
to result |
15-20
min. |
|
Units
in which the test is reported |
Available in box of 25 |
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Other
|
|
|
Product Code(s) |
05-8575 |
|
 |
Instant-View
Drugs of Abuse Cassettes |
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CLIA
Classification |
Waived |
|
CPT
Code |
G0434QW |
|
Test
methodology |
Lateral Flow Immunoassay |
|
Sample volume |
4
drops |
|
Time
to result |
4-7
min. |
|
Units
in which the test is reported |
Available in box of 25 |
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Other
|
-
Single drug tests for Amphetamines, Barbiturates,
Benzodiazepines, Buprenorphine, Cocaine, Methamphetamines,
Morphine/Opiates, Methadone, Oxycodone, Phencyclidine,
Tricyclic Antidepressants,
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Marijuana, MDMA (Ecstasy) in urine
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Sensitivity Contact Alfa for specific info
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Accuracy upto 99.75%
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24 months shelf life
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Product Code(s) |
Contact Alfa for
specific info |
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Instant-View Multi-Drug
of Abuse Urine Cup Test |
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CLIA
Classification |
Waived |
|
CPT
Code |
G0434QW |
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Test
methodology |
Lateral Flow Immunoassay |
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Sample volume |
|
|
Time
to result |
4-7
min. |
|
Units
in which the test is reported |
Available in box of 50 or 150 |
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Other
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-
Integrated test cup for Amphetamines, Barbiturates,
Benzodiazepines, Buprenorphine, Cocaine, Methamphetamines,
Morphine/Opiates, Methadone, Oxycodone, Phencyclidine,
Tricyclic Antidepressants,
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Marijuana, MDMA (Ecstasy) in urine
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With Adulteration parameter - detects variance in CR NI GL
Ph SG OX
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24 months shelf life
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Easy to use test cup with key activation
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Sensitivity Contact Alfa for specific info
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Accuracy upto 99.75%
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24 months shelf life
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|
Product Code(s) |
Contact Alfa for
specific info |
|
 |
Instant-View
Multi-Drugs of Abuse Urine
Test |
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CLIA
Classification |
Waived |
|
CPT
Code |
G0434QW |
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Test
methodology |
Lateral Flow Immunoassay |
|
Sample volume |
|
|
Time
to result |
4-7
min. |
|
Units
in which the test is reported |
Available in box of 20 or 25 |
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Other
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-
Standard panel Tests for Amphetamines, Barbiturates,
Benzodiazepines, Buprenorphine, Cocaine, Methamphetamines,
Morphine/Opiates, Methadone, Oxycodone, Phencyclidine,
Tricyclic Antidepressants,
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Marijuana, MDMA (Ecstasy) in urine
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With Adulteration parameter - detects variance in CR NI GL
Ph SG OX
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24 months shelf life
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Dip or use pipette to run test
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Sensitivity Contact Alfa for specific info
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Accuracy upto 99.75%
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24 months shelf life
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Product Code(s) |
Contact Alfa for
specific info |
|
 |
Instant-View
Pregnancy Urine Cassette Test |
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CLIA
Classification |
Waived |
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CPT
Code |
81025 |
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Test
methodology |
Lateral Flow Immunoassay |
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Sample volume |
4
drops |
|
Time
to result |
2-5
min. |
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Units
in which the test is reported |
Available in box of 25 |
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Other |
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Product Code(s) |
02-2482 |
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 |
Instant-View
Pregnancy Urine Dip-Strip Test |
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CLIA
Classification |
Waived |
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CPT
Code |
81025 |
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Test
methodology |
Lateral Flow Immunoassay |
|
Sample volume |
150
µl |
|
Time
to result |
2-5
min. |
|
Units
in which the test is reported |
Available in box of 50 |
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Other |
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Product Code(s) |
02-2487 |
|
 |
Instant-View
Pregnancy Combo Cassette
Test |
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CLIA
Classification |
Waived for urine samples
moderate for serum samples |
|
CPT
Code |
81025
for urine samples
84703
for serum samples |
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Test
methodology |
Lateral Flow Immunoassay |
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Sample volume |
4
drops |
|
Time
to result |
2-5
min. |
|
Units
in which the test is reported |
Available in box of 25 |
|
Other |
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Product Code(s) |
02-2483 |
|
 |
Instant-View
Pregnancy Combo Dip-Strip Test |
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CLIA
Classification |
Waived for urine samples
moderate for serum samples |
|
CPT
Code |
81025
for urine samples
84703
for serum samples |
|
Test
methodology |
Lateral Flow Immunoassay |
|
Sample volume |
150
µl |
|
Time
to result |
2-5
min. |
|
Units
in which the test is reported |
Available in box of 50 |
|
Other |
Sensitivity 25mIU/ml
Specificity No cross reaction with FSH/LH/TSH
Accuracy 99%
24
months of shelf life |
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Product Code(s) |
02-2488 |
|
 |
Instant-View LH
Ovulation Predicting
Cassette Test |
|
CLIA
Classification |
Waived |
|
CPT
Code |
83002QW |
|
Test
methodology |
Lateral Flow Immunoassay |
|
Sample volume |
4
drops |
|
Time
to result |
4-7
min. |
|
Units
in which the test is reported |
Available in box of 25 |
|
Other
|
-
Sensitivity 20mIU/ml
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Accuracy 99%
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24 months of shelf life
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Product Code(s) |
02-2542 |
|
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Instant-View
FSH Cassette Test |
|
CLIA
Classification |
Waived |
|
CPT
Code |
83001QW |
|
Test
methodology |
Lateral Flow Immunoassay |
|
Sample volume |
4
drops |
|
Time
to result |
4-7
min. |
|
Units
in which the test is reported |
Available in box of 25 |
|
Other
|
-
Sensitivity 40mIU/ml
-
Accuracy 99%
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24 months of shelf life
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Product Code(s) |
02-2562 |
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