CLIAwaived CLIA-RDTC-12
GUDID 00816610020655
Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) Includes adulterant testing for Creatinine, Nitrite, pH, Bleach and SG
Cliawaived, Inc.
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 00816610020655 |
| NIH Device Record Key | 2f9eab51-b417-4ad9-8363-e50741de7a66 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLIAwaived |
| Version Model Number | CLIA-RDTC-12 |
| Catalog Number | CLIA-RDTC-12 |
| 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 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816610020655 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052115
FDA Product Code
| DKZ | Enzyme Immunoassay, Amphetamine |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| 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, |
Trademark Results [CLIAwaived]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLIAWAIVED 77493425 not registered Dead/Abandoned |
CLIAWAIVED, INC. 2008-06-06 |
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