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CLIA Waived Test Kits

CLIA Waived Test Kits

The FDA policy specified that CLIA waived tests are the simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly. Now the CLIA waiver requirements are corrected and this is clear that test devices approved for home use by the Food and Drug Administration mechanically become the CLIA waived. Professional use versions of home use tests are not automatically waived. On the other hand, professional edition of such test kits do become qualified for simple waiver evaluation if the only differences between tests versions need to be studied to conclude whether the professional version qualifies for waiver.


QTEST 12  Panel Drug Test Cup CLIA Waived
QTEST 12 Panel Drug Test Cup CLIA Waived

QTEST 5 One Step Multi Drug Urine Screening Cup
QTEST 5 One Step Multi Drug Urine Screening Cup

QTEST CLIA Waived Cup 11 Panel
QTEST CLIA Waived Cup 11 Panel

7 Panel Urine Drug Screening Cup QTEST
7 Panel Urine Drug Screening Cup QTEST

Multi Drug Screen Test Kit Cup 5 panel NEW STYLE
Multi Drug Screen Test Kit Cup 5 panel NEW STYLE

THC Marijuana Drug Test Urine Cassette
THC Marijuana Drug Test Urine Cassette

BZD (Valium) Urine Drug Cassette
BZD (Valium) Urine Drug Cassette

Amphetamine Cassette Drug Urine Test
Amphetamine Cassette Drug Urine Test

Barbiturate Urine Drug Test Cassette
Barbiturate Urine Drug Test Cassette

Single Drug Test Dip Card Device
Single Drug Test Dip Card Device

New Key Split Urine Drug Test Cup for 5 Drugs
New Key Split Urine Drug Test Cup for 5 Drugs

Key Split Urine Drug Test Cup for 7 Drugs
Key Split Urine Drug Test Cup for 7 Drugs

Multi-Line Drug Test Cassette for 5 Drugs
Multi-Line Drug Test Cassette for 5 Drugs

CLIA Waived Multi-Clin Drug Screen Test Cassette for 11 Drugs (Box of 25 Tests)
CLIA Waived Multi-Clin Drug Screen Test Cassette for 11 Drugs (Box of 25 Tests)

Strep A Rapid Test Strip - BioStrep A LifeSign
Strep A Rapid Test Strip - BioStrep A LifeSign

FOBT - Home Fecal Occult Blood Test, CLIA Waived.
FOBT - Home Fecal Occult Blood Test, CLIA Waived.

Hcg Pregnancy Urine Test Cassette
Hcg Pregnancy Urine Test Cassette

hCG Pregnancy  Midstream Urine Test Kit
hCG Pregnancy Midstream Urine Test Kit

Thyrochek - CLIA Waived Thyroid Gland Rapid Test, Boxed
Thyrochek - CLIA Waived Thyroid Gland Rapid Test, Boxed

Rapid Diagnostic Strep A Test box of 25 tests
Rapid Diagnostic Strep A Test box of 25 tests

Hemosure™ One-Step Immunological Fecal Occult Blood Test (IFOBT)
Hemosure™ One-Step Immunological Fecal Occult Blood Test (IFOBT)

Alco Screen 02 DOT APPROVED Saliva Alcohol Test
Alco Screen 02 DOT APPROVED Saliva Alcohol Test

Fecal Occult Blood Test (box of 25) ForSure™
Fecal Occult Blood Test (box of 25) ForSure™

TSH Blood Test Thyro Test
TSH Blood Test Thyro Test




CPT Codes and Reimbursement Information for the CLIA Waived Test Kits
Test Description
Average Reimbursement National Limit*
CPT Code
Strep A Test Kit Strip or Device $16.76 87880QW
Drugs of Abuse Urine
Multi Drug Panel, Cassette or Cups
$20.32 For Medicare/Medicaid G0434QW
For Private Insurers 80104

Hemosure Immunological
Fecal Occult Blood Test

$22.22 Diagnostic 87774QW
Screening G0328QW
Saliva Alcohol Test Strip   82055QW
Urinary Tract Infections $3.57 81007QW  
Urinalysis Reagent Strips $3.00 81002QW  
CLIA Waived HCG Urine test $9.24 81025QW

* - The above listed Average Reimbursement Limit are provided for estimates only and are subject to change and not guaranteed. For the current actual state by state rates schedule, please visit: www.cms.hhs.gov
 


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