|
CLIA
Classification (Waived, Moderately complex):
Moderately complex
Analytes
performed on this device
|
Amphetamines:
1000 ng/ml
|
Marijuana
(THC): 50 ng/mL |
Morphine: 300, 2000 ng/ml
|
|
Barbiturates:
200 ng/ml
|
Methamphetamine:
500 ng/ml, 1000 ng/ml |
Phencyclidine: 25 ng/ml
|
|
Benzodiazepine:
300 ng/ml
|
Methadone:
300 ng/ml |
Propoxyphene: 300 ng/ml
|
|
Cocaine:
300 ng/ml
|
MDMA
(Ecstasy): 500 ng/ml |
Tricyclids (TCA): 1000 ng/ml
|
CPT
Code:
- Drug
screen, multiple classes: 80100
- Drug
Screen, single class: 80101
Test
methodology: Lateral
Flow Immunoassay
Sample
volume: About 160ml
of urine
Time to
result:
4-7 minutes
Units
in which the test is reported:
Positive or Negative (qualitative)
Other:
The
Instant-View Drug Screens are available in cassette, dip strip and
multi-panel formats. Each format includes a built-in control. The
multi-panel can test from 2 to 12 analytes at one time and can use
a dip and read procedure or the transfer pipette method. The tests
are FDA 510(k)-cleared and manufactured in the U.S.
CLIA
Classification (Waived, Moderately complex):
Waived
Analytes
performed on this device:
Human Chorionic Gonadotropin (hCG) and human Luteinizing Hormone (LH)
CPT
Code:
- Pregnancy,
urine: 81025
- Ovulation
(LH): 84830
- Pregnancy, serum: 84703
Test
methodology: Lateral
Flow Immunoassay
Sample
volume: About 160ml
of urine
Time to
result: 2-3
minutes
Units
in which the test is reported: Positive
or Negative (qualitative)
Other:
The
Instant-View Fertility tests are FDA 510(k)-cleared and
manufactured in the U.S.
CLIA Classification (Waived,
Moderately complex):
Waived
Analytes performed on this
device:
human hemoglobin
CPT Code:
82274
Test methodology:
Lateral Flow Immunoassay
Sample volume: About
160ml
of specimen sample in extraction buffer
Time to result:
5-10 minutes
Units in which the test is
reported: Positive or
Negative (qualitative)
Advantages:
-
Cut-off
level = 50 μg hHb/g feces
-
Economical,
convenient, odor-free collection tube maintains the integrity
of the specimen sample
-
Specifically
designed collection tube allows short and long-term specimen
storage: 12-14 days at 15-30°C,
2 months at 4°C
or 2 years at -20°C
-
Specimen
collection tube doubles as applicator for use with the test
cassette
-
No
dietary restrictions
-
510(k)-cleared
and manufactured in the U.S.
|