FDA.reportPublic FDA data

CLIAwaived

Primary DI
00816610020105
Brand
CLIAwaived
Company
Cliawaived, Inc.
Model
CLIA-RDDT-52
Catalog number
CLIA-RDDT-52
Device description
Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022355000QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61Branan Medical Corp.2002-07-30DIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816610020105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816610020105008166100201058166100201050816610020105

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-882-7739info@cliawaived.com

Regulatory Flags#

DUNS number
969635304
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816610020884CLIAwaivedCLIA-IDTC-5-65569CLIA-IDTC-5-655692016-10-26
00816610020785CLIAwaivedCLIA-IDTC-11-NTHCCLIA-IDTC-11-NTHC2016-10-26
00816610020808CLIAwaivedCLIA-IDTC-12BUPaCLIA-IDTC-12BUPa2016-10-26
00816610020822CLIAwaivedCLIA-IDTC-5-60527a CLIA-IDTC-5-60527a 2016-10-26
00816610020846CLIAwaivedCLIA-IDTC-5-60579CLIA-IDTC-5-605792016-10-26
00816610020860CLIAwaivedCLIA-IDTC-5-60527CLIA-IDTC-5-605272016-10-26
00816610020914CLIAwaivedCLIA-IDTC-6-60669CLIA-IDTC-6-606692016-10-26
00816610020921CLIAwaivedCLIA-IDTC-7-60717CLIA-IDTC-7-607172016-10-26
00816610020938CLIAwaivedCLIA-IDTC-7BUPCLIA-IDTC-7BUP2016-10-26
00816610020174CLIAwaivedCLIA-SDDT-14CLIA-SDDT-142016-09-01
00816610020181CLIAwaivedCLIA-SDDT-16CLIA-SDDT-162016-09-01
00816610020242CLIAwaivedCLIA-SDDT-22CLIA-SDDT-222016-09-01
00816610020143CLIAwaivedCLIA-SDDT-10CLIA-SDDT-102016-09-01
00183278000443CLIAWAIVED INCCLIA-INGM-MC42SCLIA-INGM-MC42S2020-03-27
00183278000436CLIAWAIVED INCCLIA-INGM-MC42CLIA-INGM-MC422020-03-26
00816610020402CLIAWAIVED INCTHYROCHEK-120-A-KITTHYROCHEK-120-A-KIT2019-03-29
00816610020440CLIAWAIVED INCCLIA-TSH-120-A-KITCLIA-TSH-120-A-KIT2019-03-29
00816610020068CLIAwaivedCLIA-12-RDTC-BUP-ACLIA-12-RDTC-BUP-A2016-09-01
00816610020075CLIAwaivedCLIA-RDDT-13CLIA-RDDT-132016-09-01
00816610020082CLIAwaivedCLIA-14-RDTC-ACLIA-14-RDTC-A2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJC2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.LDJ2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.JXM2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DIO2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2016-09-23