ALFA’s CLIA-waived products
ALFA offers a wide variety of CLIA-products. Would you like to place an order? Please click the ‘contact us’ button. Our customer service and sales teams are here to help you.
| PRODUCT | DESCRIPTION | FORMAT | KIT SIZE | ALFA# | |||||
|---|---|---|---|---|---|---|---|---|---|
| Test Type: Drugs of Abuse | |||||||||
| Instant-View Buprenorphine Urine DipCassette Test | Instant-View Buprenorphine (BUP) Urine Test, cut off: 10 ng/ml | Dip Cassette | 25 Tests | 03-2842QW | |||||
| Instant-View Oxycodone Urine DipCassette Test | Instant-View Oxycodone (OXY100) Urine Test, cut off: 100 ng/ml | Dip Cassette | 25 Tests | 03-2862QW | |||||
| Instant-View MDMA (Ecstasy) Urine DipCassette Test | Instant-View MDMA (XTC) Urine Test, cut off: 500 ng/ml | Dip Cassette | 25 Tests | 03-2952QW | |||||
| Instant-View Tricyclic Antidepressants Urine DipCassette Test | Instant-View Tricyclic Antidepressants (TCA) Urine Test, cut off: 1000 ng/ml | Dip Cassette | 25 Tests | 03-2972QW | |||||
| Instant-View Amphetamine Urine DipCassette Test | Instant-View Amphetamine (AMP) Urine Test, cut off: 1000 ng/ml | Dip Cassette | 25 Tests | 03-3012QW | |||||
| Instant-View MET1000 Urine DipCassette Test | Instant-View Methamphetamine1000 (MET1000) Urine Test, cut off: 1000 ng/ml | Dip Cassette | 25 Tests | 03-3032QW | |||||
| Instant-View Cocaine300 Urine DipCassette Test | Instant-View Cocaine (COC) Urine Test, cut off: 300 ng/ml | Dip Cassette | 25 Tests | 03-3052QW | |||||
| Instant-View THC Urine DipCassette Test | Instant-View Marijuana (THC) Urine Test, cut off: 50 ng/ml | Dip Cassette | 25 Tests | 03-3072QW | |||||
| Instant-View MOR/OPI2000 Urine DipCassette Test | Instant-View Morphine/Opiate 2000 (MOR/OPI2000) Urine Test, cut off: 1000 ng/ml | Dip Cassette | 25 Tests | 03-3092QW | |||||
| Instant-View MOR/OPI300 Urine DipCassette Test | Instant-View Morphine/Opiate 300 (MOR/OPI300) Urine Test, cut off: 300 ng/ml | Dip Cassette | 25 Tests | 03-3093QW | |||||
| Instant-View PCP Urine DipCassette Test | Instant-View Phencyclidine (PCP) Urine Test, cut off: 25 ng/ml | Dip Cassette | 25 Tests | 03-3112QW | |||||
| Instant-View Benzodiazepine Urine DipCassette Test | Instant-View Benzodiazepine (BZD) Urine Test, cut off: 300 ng/ml | Dip Cassette | 25 Tests | 03-3132QW | |||||
| Instant-View Barbiturate Urine DipCassette Test | Instant-View Barbiturate (BAR) Urine Test, cut off: 200 ng/ml | Dip Cassette | 25 Tests | 03-3152QW | |||||
| Instant-View Methadone Urine DipCassette Test | Instant-View Methadone (MTD) Urine Test, cut off:300 ng/ml | Dip Cassette | 25 Tests | 03-3172QW | |||||
| Instant View Multi Drug M4 Urine Test | Instant-View M4 (BZD COC MOR MTD) Dip Test | Panel | 25 Tests | 03-3427QW | |||||
| Instant View Multi Drug M5 Urine Test | Instant-View M5 (BZD COC MET MOR THC) Dip Test | Panel | 25 Tests | 03-3571QW | |||||
| Instant View Multi Drug M5 Urine Test | Instant-View M5 (AM CO MO PC TH) Dip Test | Panel | 25 Tests | 03-3576QW | |||||
| Instant View Multi Drug M5 Urine Test | Instant-View M5 (AM BA BZ MT OX) Dip Test | Panel | 25 Tests | 03-5050 | |||||
| Instant View Multi Drug M5 Urine Test | Instant-View M5 (BZ CO MO300 MT TH) Dip Test | Panel | 25 Tests | 03-5051 | |||||
| Instant View Multi Drug M6 Urine Test | Instant-View M6 (AM BZ CO ME MO TH) Dip Test | Panel | 25 Tests | 03-3635QW | |||||
| Instant View Multi Drug M8 Urine Test | Instant-View M8 (AM BA BZ CO MO MT OX TC) Dip Test | Panel | 20 Tests | 03-3862QW | |||||
| Instant View Multi Drug M9 Urine Test | Instant-View M9 (AM BA BZ CO ME MO MT PC TH) Dip Test | Panel | 20 Tests | 03-3997QW | |||||
| Instant View Multi Drug M10 Urine Test | Instant-View M10 (AM BA BZ CO ME MO MT PC TC TH) Dip Test | Panel | 20 Tests | 03-3910QW | |||||
| Instant View Multi Drug M11 Urine Test | Instant-View M11 (AM BA BZ CO ME MO MT PC TC TH XT) Dip Test | Panel | 20 Tests | 03-3940QW | |||||
| Instant View Multi Drug M12 Urine Test | Instant-View M12 (AM BA BZ CO ME MO300 MT OX100 PC TC TH XT) Dip Test | Panel | 20 Tests | 03-3965QW | |||||
| Test Type: Health | |||||||||
| Instant View IFOB Cassette Test | Instant-View FOB Fecal Test, Cut off: 50 ng/ml | Cassette | 25 Tests | 05-7602 | |||||
| Test Type: Fertility | |||||||||
| Instant View FSH Urine DipStrip Test | Instant-View FSH Urine Test, Cut-off: 40 mIU/ml | Dip Strip | 50 Tests | 02-2567 | |||||
| Instant View FSH Urine Cassette Test | Instant-View FSH Urine Test, Cut-off: 40 mIU/ml | Cassette | 25 Tests | 02-2562 | |||||
| Instant View LH Urine Strip Test | Instant-View LH Urine Test, Cut-off: 20 mIU/ml | Dip Strip | 50 Tests | 02-2547 | |||||
| Instant View LH Urine Cassette Test | Instant-View LH Urine Test, Cut-off: 20 mIU/ml | Cassette | 25 Tests | 02-2542 | |||||
| Instant View hCG Urine Strip Test | Instant-View HCG Urine Test, Cut-off: 25 mIU/m | Dip Strip | 50 Tests | 02-2487 | |||||
| Instant View hCG Urine Cassette Test | Instant-View HCG Urine Test, Cut-off: 25 mIU/m | Cassette | 25 Tests | 02-2482 | |||||
What Is CLIA?
Often we are asked by distributors why it is important for a test to be CLIA-Waived. Well to answer that question it is first best to explain what CLIA stands for. The Clinical Laboratory Improvement Amendments of 1988 specifies that laboratory requirements must be based on the complexity of the test performed. As a result they established provisions for categorizing a test as Waived.
If tests meet the requirements set by this statute, then they may be waived from regulatory oversight. On February 28, 1992, regulations were published to implement CLIA.
Do I Need A CLIA-Waived Test?
CLIA requirements do apply to entities that perform test on …”materials derived from the human body for the purpose of providing information for diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings” to meet certain Federal requirements. If the tests are performed for these purposes, the organization doing so is considered under CLIA to be a laboratory and must register with the CLIA program. In these instances, the advantage of using a “CLIA Waived” test is that it “waives” you from having to comply with a long list of laboratory requirements (such as quality control, training, etc).
CLIA regulations do not apply to settings such as Correctional (i.e. jails, prisons, probation, courts, etc.) or even Workplace markets. However CLIA-Waived tests can still be sold to them as if they were not Waived at all. As distributors typically sell to multiple end user markets, having a selection of CLIA-Waived tests is advantageous as it avoids limiting their sales avenues.
Additional information on CLIA can be found at http://www.fda.gov/cdrh/clia/cliaWaived.html.
For state by state reimbursement fee schedule go to www.cms.hhs.gov.
How ALFA Can Help
At Alfa Scientific, our key area of focus is in Drugs of Abuse Testing. As such, we have several “novel” products which would be of interest to any distributor competing in the Drugs of Abuse market. View our CLIA-Waived Products.
