CLIAwaived CLIA-12-RDTC-A

GUDID 00816610021058

Rapid Drug Test Cup for (THC/COC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Adulteration Tests CR, NI, PH, BL, SG

Cliawaived, Inc.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID00816610021058
NIH Device Record Key8027bdde-3912-4ebe-b3de-b91c3be4aa71
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLIAwaived
Version Model NumberCLIA-12-RDTC-A
Catalog NumberCLIA-12-RDTC-A
Company DUNS969635304
Company NameCliawaived, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816610021058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LAFGas Chromatography, Methamphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-28

On-Brand Devices [CLIAwaived]

00816610021058Rapid Drug Test Cup for (THC/COC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with
00816610020938CLIAwaived,Inc. IDTC- 7 Panel Drug Screen (CR,SG,OX) for (COC/MET/MOP/MTD/BZO/OXY/BUP)
00816610020921CLIAwaived,Inc. One Step Drug Test Cup-7 panel configuration (THC,COC,OPI 300,mAMP,MTD,OXY, BZO)
00816610020914CLIAwaived,Inc. One Step Drug Test Cup-6 panel configuration (OPI300,BZO,BAR,MTD,OXY, TCA) -(25T
00816610020860CLIAwaived,Inc. IDTC- 5 Panel Cup (COC 300,MET 1000,OPI 300, OXY 100, THC 50)-(25T/KIT)
00816610020846CLIAwaived,Inc. IDTC- 5 Panel Drug Test Cup (COC,mAMP,OPI300, OXY, MTD)-(25T/KIT)
00816610020844CLIAwaived,Inc. One Step Drug Test Cup-5 panel with Adulterants (COC,OPI300,mAMP,OXY, MTD + Cr,
00816610020822CLIAwaived,Inc. IDTC- 5 Panel Cup with Adulterants (CR, SG, OX) (COC 300,MET 1000,OPI 300, OXY 1
00816610020808CLIAwaived,Inc. IDTC- 12 Panel Cup with Adulterants (THC, COC, OPI 300, AMP, mAMP, PCP, BAR, BZO
00816610020785CLIAwaived,Inc. IDTC- 11 Panel Cup with no THC (COC, OPI 300, AMP, mAMP, PCP, BAR, BZO, MTD, OXY
00816610020662Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)
00816610020655Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) Inc
00816610020648Single Drug Dipstick Test for THC50/COC300/OPI300/MTD300
00816610020631Single Drug Dipstick Test for THC50/COC300/OPI300/BZO300
00816610020624Single Drug Dipstick Test for BZO300/BAR300/MTD300/OXY100
00816610020266Single Drug Dipstick Test for BUP10
00816610020259Single Drug Dipstick Test for OXY100
00816610020242Single Drug Dipstick Test for MDMA500
00816610020235Single Drug Dipstick Test for TCA1000
00816610020228Single Drug Dipstick Test for MTD300
00816610020211Single Drug Dipstick Test for BAR300
00816610020204Single Drug Dipstick Test for BZO300
00816610020198Single Drug Dipstick Test for PCP25
00816610020181Single Drug Dipstick Test for MET500
00816610020174Single Drug Dipstick Test for AMP1000
00816610020167Single Drug Dipstick Test for OPI300
00816610020150Single Drug Dipstick Test for COC300
00816610020143Single Drug Dipstick Test for THC50
00816610020136Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDM
00816610020129Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDM
00816610020112Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/PCP25/BZO300/MTD300/OXY100/BUP10
00816610020105Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100
00816610020099Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100 + CR/NI/P
00816610020082Rapid Drug Test Cup for (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA10
00816610020075Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/BZO300
00816610020068Rapid Drug Test Cup for (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA10
00816610020884CLIAwaived,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
CLIAWAIVED
77493425 not registered Dead/Abandoned
CLIAWAIVED, INC.
2008-06-06
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