CLIAwaived CLIA-14-RDTC-A

GUDID 00816610020082

Rapid Drug Test Cup for (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000)(MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG

Cliawaived, Inc.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00816610020082
• NIH Device Record Key: 4ba354a2-7b43-48ed-a94b-da306b53bf09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLIAwaived
• Version Model Number: CLIA-14-RDTC-A
• Catalog Number: CLIA-14-RDTC-A
• Company DUNS: 969635304
• Company Name: Cliawaived, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com
• Phone: 1-888-882-7739
• Email: info@cliawaived.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816610020082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122633

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-15
• Device Publish Date: 2016-09-01

On-Brand Devices [CLIAwaived]

• 00816610021058: Rapid Drug Test Cup for (THC/COC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with
• 00816610020938: CLIAwaived,Inc. IDTC- 7 Panel Drug Screen (CR,SG,OX) for (COC/MET/MOP/MTD/BZO/OXY/BUP)
• 00816610020921: CLIAwaived,Inc. One Step Drug Test Cup-7 panel configuration (THC,COC,OPI 300,mAMP,MTD,OXY, BZO)
• 00816610020914: CLIAwaived,Inc. One Step Drug Test Cup-6 panel configuration (OPI300,BZO,BAR,MTD,OXY, TCA) -(25T
• 00816610020860: CLIAwaived,Inc. IDTC- 5 Panel Cup (COC 300,MET 1000,OPI 300, OXY 100, THC 50)-(25T/KIT)
• 00816610020846: CLIAwaived,Inc. IDTC- 5 Panel Drug Test Cup (COC,mAMP,OPI300, OXY, MTD)-(25T/KIT)
• 00816610020844: CLIAwaived,Inc. One Step Drug Test Cup-5 panel with Adulterants (COC,OPI300,mAMP,OXY, MTD + Cr,
• 00816610020822: CLIAwaived,Inc. IDTC- 5 Panel Cup with Adulterants (CR, SG, OX) (COC 300,MET 1000,OPI 300, OXY 1
• 00816610020808: CLIAwaived,Inc. IDTC- 12 Panel Cup with Adulterants (THC, COC, OPI 300, AMP, mAMP, PCP, BAR, BZO
• 00816610020785: CLIAwaived,Inc. IDTC- 11 Panel Cup with no THC (COC, OPI 300, AMP, mAMP, PCP, BAR, BZO, MTD, OXY
• 00816610020662: Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)
• 00816610020655: Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) Inc
• 00816610020648: Single Drug Dipstick Test for THC50/COC300/OPI300/MTD300
• 00816610020631: Single Drug Dipstick Test for THC50/COC300/OPI300/BZO300
• 00816610020624: Single Drug Dipstick Test for BZO300/BAR300/MTD300/OXY100
• 00816610020266: Single Drug Dipstick Test for BUP10
• 00816610020259: Single Drug Dipstick Test for OXY100
• 00816610020242: Single Drug Dipstick Test for MDMA500
• 00816610020235: Single Drug Dipstick Test for TCA1000
• 00816610020228: Single Drug Dipstick Test for MTD300
• 00816610020211: Single Drug Dipstick Test for BAR300
• 00816610020204: Single Drug Dipstick Test for BZO300
• 00816610020198: Single Drug Dipstick Test for PCP25
• 00816610020181: Single Drug Dipstick Test for MET500
• 00816610020174: Single Drug Dipstick Test for AMP1000
• 00816610020167: Single Drug Dipstick Test for OPI300
• 00816610020150: Single Drug Dipstick Test for COC300
• 00816610020143: Single Drug Dipstick Test for THC50
• 00816610020136: Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDM
• 00816610020129: Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDM
• 00816610020112: Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/PCP25/BZO300/MTD300/OXY100/BUP10
• 00816610020105: Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100
• 00816610020099: Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100 + CR/NI/P
• 00816610020082: Rapid Drug Test Cup for (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA10
• 00816610020075: Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/BZO300
• 00816610020068: Rapid Drug Test Cup for (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA10
• 00816610020884: CLIAwaived,Inc. One Step Drug Test Cup-5 panel with Adulterants (COC,OPI300,mAMP,OXY, MTD + Cr,