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CLIA Waived Drug Tests


Clinical Laboratory Improvement Amendments (CLIA)

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.

A laboratory is any facility that does laboratory testing on specimens derived from humans to give information for the diagnosis, prevention, treatment of disease, or impairment of or assessment of health.

The categorization of commercially marketed in vitro diagnostic tests under CLIA is the responsibility of the FDA. This categorization includes the process of assigning commercially marketed in vitro diagnostic test systems to one of three CLIA regulatory categories based on their potential for risk to public health:

  • Tests of Moderate Complexity
  • Tests of High Complexity
In Conclusion, CLIA Waived drug tests are to be used:
  • When Screening Patients for Diagnosis
  • When Screening for the Purpose of Disease Prevention
  • When Screening for the Treatment of Disease
  • When Screening for the Assessment of Health
  • When Screening for the Assessment of an Impairment

Be aware, not all in-vitro drug tests are Waived, if the product description does not mention a CLIA Waiver then most likely it is not. Usually, only certain configurations of a drug testing product line are CLIA Waived, so do not make the mistake in assuming that it is. CLIA Waivers for drug tests are not easy to attain and can be costly and timely. Lots of factors are involved as to the quality and accuracy of the test, making sure that there is no risk to the patient. The old cliche rings true that "you get what you pay for" so when looking for the right product, keep that in mind. As we all know, liability and risk are standard worries. When wondering which drug test is right for you, an established brand with a proven track record will remain the safe choice.

The following drug testing products are classified as CLIA Waived to meet the needs of your testing facility. CLIA Waived drug tests have been cleared through a review process of two U.S. government agencies: the FDA and HCFA, the objective of this is to determine that errors in operation will be minimized and that inaccurate test results will not endanger the life of the patient. A CLIA waiver is specific to the manufacturer and the product. Each test method is individually examined before a waiver is granted.

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Multi-CLIN 11 CLIA Waived Cassette MULTI CLIN 11 CLIA Waived Cassette

#DCB-1115-011: (COC THC OPI AMP PCP BZO BAR MDMA PPX OXY TCA)

  • FDA 510(k) Cleared
  • CLIA Waived
  • 11 Panel Urine Drug Test
  • Box of 25
Multi-Clin 11 panel instant drug test cassette. FDA Cleared drug test cassette is equipped with integrated positive and negative controls built-in. Clinical drug test cassette (FDA 510K#: K041685).

Our Price: $239.00 Before Discount
ToxCup 14 Panel Clia Waived Cup ToxCup 14 Panel CLIA Waived cup

# DT-14: (AMP BAR BUP BZO COC MDMA MAMP MTD OPI OXY PCP PPX TCA THC)

  • CLIA Waived
  • U.S. FDA approved
  • Results in 5 minutes
  • Box of 25
14 panel ToxCup for point of care on-site instant drug testing.

Our Price: $229.95 Before Discount

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AmediCheck 12 Panel CLIA Waived Cup AmediCheck 12 Panel CLIA Waived Cup

# NM-C-C-1202A: (AMP BAR BZO COC mAMP MDMA MTD OPI OXY PCP THC TCA)

  • Made in the U.S.A.
  • Box of 25
  • 12 panel drug screen
  • Leak Proof
The AmediCheck instant test cup is an in vitro diagnostic test for the rapid detection of drugs in human urine. This test is intended for over-the-counter (OTC) consumer use.

Our Price: $199.95 Before Discount
One Step Cup 12 Panel Clia Waived Cup One Step 12 Panel CLIA Waived cup

# NM-NBCA-12M-W: (COC THC AMP mAMP BZO BAR MTD MDMA OXY TCA OPI PCP) + AD (CR NI PH OX SG)

  • CLIA Waived
  • FDA Approved
  • Built-in Adulteration
  • Box of 25
12 panel drug screen cup for point of care on-site drug testing purposes.

Our Price: $195.00 Before Discount
Uscreen 12 panel drug test + AD Uscreen 12 panel Cup + AD

# USSCupA-12BUP-300CLIA: (AMP BAR BUP BZO COC mAMP MDMA MOP MTD OXY PCP THC) + AD (CR SG PH)

  • CLIA Waived
  • Fast, Dark Test Lines
  • Results in minutes
  • Box of 25
UScreen instant drug test cup detects 12 different drugs.

Our Price: $169.50 Before Discount
Uscreen 10 panel drug test + AD Uscreen 10 panel Cup + AD

# USSCupA-10MOB-300CLIA: (AMP BUP BZO COC mAMP MDMA MTD MOP OXY THC) + AD (CR SG OX)

  • CLIA Waived
  • Fast, Dark Lines
  • Results in minutes
  • Box of 25
UScreen features: easy one-step operation rest assured there is zero exposure to donor specimen and the donor cannot defeat assay.

Our Price: $160.95 Before Discount
   
 
Use Rapid Detect CLIA Waived Drug Tests when testing for diagnosis, prevention, treatment of disease, impairment of, or assessment of health.