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CLIA waived

CLIA Waived Drug Test Cups and Kits

CLIA waived means the FDA has categorized the test as simple to perform. A site that uses waived tests for clinical purposes still needs a CLIA Certificate of Waiver from CMS and must follow the manufacturer's instructions.

We sell 32 CLIA waived cups from 5 to 16 panels and 19 CLIA waived strips and dip cards, from $0.79 a cup at 20,000+.

CLIA waived cups by panel count

Every CLIA waived cup

PanelsCupSizeDrugs and cutoffs (ng/mL)Price per cup
1212 Panel Drug Test (120ml)Detects PCP, OXY, COC, METH, OPI & More, CLIA Waived, Serenity Click CupSM-CDOA-6125120 mLPCP25AMP1,000OPI300MET1,000BZO300COC300MTD300OXY100BUP10THC50BAR300MDMA500$2.89 at 25+$1.69 at 20,000+
1212 Panel Drug Test Cup, TCA, CLIA WaivedSM-CDOA-7125120 mLTCA1,000AMP1,000OPI300MET1,000BZO300COC300MTD300OXY100BUP10MDMA500THC50BAR300$2.89 at 25+$1.69 at 20,000+
1313 Panel Drug Test Detects Fentanyl 1ng, CLIA WaivedSM-CDOA-4135CLIA120 mLFEN1AMP500BAR300BUP10BZO300COC150MDMA500MET500OPI300MTD300OXY100PCP25THC50$2.99 at 25+$1.79 at 20,000+
1414 Panel Drug Test Cup detects Fentanyl, CLIA Waived with EDDP & TCA, Clearance!SM-CDOA-9145CLIA120 mLFEN1AMP500BAR300BUP10BZO300COC150EDDP300MDMA500MET500OPI300MTD300OXY100TCA1,000THC50$2.99 at 25+$1.59 at 20,000+
1212 Panel Drug Test Cup 90ml: CLIA Waived, Serenity Urine Test CupSM-CDOA-6125-9090 mLPCP25AMP1,000OPI300MET1,000BZO300COC300MTD300OXY100BUP10MDMA500THC50BAR300$2.79 at 25+$1.59 at 20,000+
1212 Panel Drug Test Detects TCA,OPI, OXY, METH, Adulterants, & More CLIA WaivedSM-CDOA-8125AD3 · adulterant check120 mLTCA1,000AMP1,000OPI300MET1,000BZO300COC300MTD300OXY100BUP10MDMA500THC50BAR300$2.89 at 25+$1.69 at 20,000+
1010 Panel Drug Test Cups AMP, MET, THC, MTD, OPI, OXYSM-CDOA-4105120 mLMDMA500OXY100BUP10AMP1,000OPI300MET1,000BZO300COC300MTD300THC50$2.69 at 25+$1.59 at 20,000+
1515 Panel Drug Test Cup Detects Fentanyl, Nor Fentanyl & EDDP, CLIA Waived- Clearance!SM-CDOA-9155CLIA120 mLFEN1NFEN5AMP500BAR300BUP10BZO300COC150EDDP300MDMA500MET500OPI300MTD300OXY100PCP25THC50$3.09 at 25+$1.89 at 20,000+
88 Panel Drug Test Cup, CLIA Waived, Detecting AMP, BZO, BUP, COC, THC, MET, OPI & OXYSM-CDOA-285120 mLTHC50BUP10AMP1,000BZO300COC300OXY100$2.19 at 25+$1.09 at 20,000+
55 Panel Drug Test Cup CLIA Waived Detecting THC, COC, AMP, OPI and PCPSM-CDOA-255120 mLOPI300THC50PCP25AMP1,000COC300$1.79 at 25+$0.89 at 20,000+
66 Panel Drug Test Cup, CLIA Waived Detecting AMP, OPI, BUP, BZO, COC, OXY- 120ml Large cupSM-CDOA-265120 mLBUP300BZO300AMP1,000OPI300COC300OXY100$1.97 at 50+$0.99 at 20,000+
1010 Panel Cup 90 mlSM-CDOA-7105-9090 mLBUP10MDMA500AMP1,000OPI300MET1,000BZO300COC300MTD300OXY100THC50$2.59 at 25+$1.39 at 20,000+
1616 panel CLIA Waived 16 Panel Drug Test Cup, detects Fentanyl 1ng, PPX, TCA and TMLSM-CDOA-7165CLIANot listedAMPBARBUPBZOCOCMDMAMETMTDOPIOXYPCPPPXTCATHCFEN1NG/MLTRA$3.39 at 25+$1.99 at 20,000+
55 Panel Test, CLIA Waived Detecting BZO, COC, THC, METH, MOP & AdulterantsSM-CDOA-654AD3 · adulterant check120 mLBZO300OPI2,000COC300MET1,000THC50$1.59 at 25+$0.79 at 20,000+
1212 Panel Drug Test Cup with Fentanyl 1 ng/mL -, CLIA WaivedSM-CDOA-4125CLIA120 mLFEN1AMP500BAR300BUP10BZO300COC150MDMA500MET500OPI300MTD300OXY100THC50$2.89 at 25+$1.69 at 20,000+
1010 Panel Drug Test Cup with Fentanyl -, CLIA WaivedSM-CDOA-6105CLIA120 mLAMP500BUP10BZO300COC150MET500MTD300OPI300OXY100THC50$2.69 at 25+$1.59 at 20,000+
55 Panel Drug Test Detecting AMP, COC, THC, MOP, MAMP., CLIA WaivedSM-CDOA-254AD3 · adulterant check120 mLMET1,000AMP1,000COC300OPI2,000THC50$1.79 at 25+$0.89 at 20,000+
55 Panel Test Cup Detecting Adulterations, AMP, COC, PCP, THC and OPI,Click Top Lid &, CLIA WaivedSM-CDOA-154AD3 · adulterant checkNot listedOPI2,000PCP25AMP1,000COC300$1.77 at 50+$0.89 at 20,000+
55 panel 90ML Urine Test Cup 5 Panel with OPI/300 & OXYSM-CDOA-855-9090 mLOPI300OXY100AMP1,000COC300MET1,000$1.65 at 50+$0.79 at 20,000+
55 panel 90ML Urine Test Cup 5 Panel with PCP & AdulterantsSM-CDOA-154AD3-90 · adulterant check90 mLOPI2,000THC50PCP25AMP1,000COC300$1.65 at 50+$0.79 at 20,000+
1010 Panel CLIA Waived Multi-Drug Urine Test Cup 120ML detecting THC, OXY, BZO, BUP, COC, METH, MOP, MTD, MDMA, AMP, low as $0.99SM-CDOA-8104120 mLOPI2,000THC50AMP1,000BZO300BUP10COC300MDMA500MET1,000MTD300OXY100$1.99 at 25+$0.99 at 20,000+
1414 Panel Urine Drug Test Cup 90ML, CLIA Waived Detects PPX, OPI/2000, BUP, OXY, BZO, PCP, TCA & AdulterantsSM-CDOA-1144AD3-90 · adulterant check90 mLTCA1,000PPX300AMP1,000BAR300BUP10BZO300COC300MDMA500MET1,000MTD300OPI2,000OXY100PCP25THC50$2.99 at 25+$1.79 at 20,000+
77 Panel Drug Test Cup 90ml CLIA Waived Detecting MET & OPI/2000SM-CDOA-274-9090 mLTHC50OPI2,000AMP1,000COC300BZO300MET1,000OXY100$1.65 at 50+$0.89 at 10,000+
1111 Panel CLIA Multi-Drug Urine Test Cup detecting OXY, MDMA, MOP, BZO, COC PCP,BUP and MoreSM-CDOA-10115120 mLAMP1,000BAR300BUP10BZO300COC300MET1,000MDMA500OPI300MTD300OXY100PCP25$2.79 at 25+$1.59 at 20,000+
66 Panel Cup Detecting AMP, COC, MET, OPI, PCP, & THC, CLIA WaivedSM-CDOA-164120 mLPCP25OPI2,000THC50AMP1,000COC300MET1,000$1.99 at 25+$0.99 at 20,000+
66 panel 90ML Urine Test Cup 6 Panel with BZO, THC & AdulterantsSM-CDOA-264AD3-90 · adulterant check90 mLOPI2,000BZO300THC50AMP1,000COC300MET1,000$1.87 at 50+$0.89 at 20,000+
77 Panel Drug Test Cup,120ml, Detecting, AMP, BZO, COC, THC, MET, OPI & OXYSM-CDOA-274120 mLTHC50AMP1,000BZO300COC300MET1,000OPI2,000OXY100$1.59 at 25+$0.99 at 20,000+
1414 Panel Drug Test Cup with Tramadol & Fentanyl, CLIA WaivedSM-CDOA-8145F1T · adulterant checkNot listedFEN1AMP500BAR300BUP10BZO300COC150MET500MDMA500OPI300MTD300OXY100PCP25THC50TRA100$3.19 at 25+$1.89 at 20,000+
66 Panel Drug Test Cup 90ml, CLIA Waived Detecting BZO, COC, MET, OPI, OXY and THCSM-CDOA-564-9090 mLTHC50OPI2,000BZO300COC300MET1,000OXY100$1.55 at 50+$0.89 at 10,000+
66 Panel Test Cup CLIA Waived, Detecting AMP, COC, BZO, MET, OPI, THC & Adulterations, PH/SG/CR, 120mlSM-CDOA-264AD3 · adulterant check120 mLBZO300OPI300AMP1,000COC300MET1,000THC50$1.99 at 25+$0.99 at 20,000+
66 panel 90ML Urine Test Cup 6 Panel with OPI & AdulterationsSM-CDOA-365AD3-90 · adulterant check90 mLTHC50OPI300AMP1,000MET1,000BZO300COC300$1.55 at 50+$0.89 at 10,000+
77 Panel Urine Drug Test Cup 90ML CLIA Waived Detecting OXY, MTD & OPISM-CDOA-975-9090 mLOPI300OXY100AMP1,000BAR300BZO300COC300MTD300$1.59 at 25+$0.89 at 10,000+

Drugs and cutoffs are taken from each product's label. Always follow the package insert for the specific test. Looking for the other label? Forensic Use Only cups

CLIA waived strips and dip cards

How to read the result

Negative
Two colored lines appear: one in the control region (C) and one in the test region (T) for that drug. A line in T of any intensity, even a faint one, means negative for that drug.
Preliminary positive
Only one colored line appears, in the control region (C). No line appears in the test region (T) for that drug. This means the drug may be present at or above the cutoff level.
Invalid
No line appears in the control region (C). Discard the test and repeat with a new device. If it happens again, contact us.

Always follow the package insert for the specific test. Preliminary positive results should be confirmed by a laboratory using GC-MS or LC-MS/MS.

Questions about CLIA waived tests

What does CLIA waived mean?

CLIA waived means the FDA has categorized the test as simple to perform. A site that uses waived tests for clinical purposes still needs a CLIA Certificate of Waiver from CMS and must follow the manufacturer's instructions.

Do I need a CLIA certificate to use these tests?

A site that uses waived tests for clinical purposes needs a CLIA Certificate of Waiver from CMS and must follow the manufacturer's instructions. Check with CMS or your state agency for what applies to your program.

How do I check that a test is CLIA waived?

The FDA publishes a database of CLIA-categorized tests. Look up the test by its name or the drug it detects, and compare it with the package insert of the product you buy. We can send the insert for any product.

Which CLIA waived cups test for fentanyl?

5 of our 32 CLIA waived cups include a fentanyl strip, at 1 ng/mL.

Can CLIA waived cups be used for DOT testing?

No. Instant (point-of-collection) tests can't be used for DOT-required testing. Under 49 CFR Part 40, DOT tests must be collected on a federal custody and control form and analyzed at an HHS-certified laboratory. Instant cups, dip cards and oral swabs are for non-DOT programs, such as company-policy pre-employment, random, reasonable-suspicion and post-accident testing.

Do positive results need to be confirmed?

Yes. A positive result on an instant test is preliminary. Before any legal, employment or clinical action, have the specimen confirmed by a certified laboratory using GC-MS or LC-MS/MS. 12 Panel Now isn't affiliated with a specific laboratory, so customers arrange confirmation testing independently.