FDA.reportPublic FDA data

CLIAwaived

Primary DI
00816610020808
Brand
CLIAwaived
Company
Cliawaived, Inc.
Model
CLIA-IDTC-12BUPa
Catalog number
CLIA-IDTC-12BUPa
Device description
CLIAwaived,Inc. IDTC- 12 Panel Cup with Adulterants (THC, COC, OPI 300, AMP, mAMP, PCP, BAR, BZO, MTD, OXY, MDMA, BUP + Cr, SG, OX)-(25T/KIT)
Published
2016-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133968000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133968000WONDFO MULTI-DRUG URINE TEST CUP, PANELGuangzhou Wondfo Biotech Co., Ltd.2014-02-25DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816610020808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816610020808008166100208088166100208080816610020808

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 Temperature4 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
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
00816610020099CLIAwaivedCLIA-RDDT-52ACLIA-RDDT-52A2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656702AccurateHealgen Scientific Limited Liability CompanyLDJ2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDIO2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyLAF2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyJXM2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDIS2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJR2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyLCM2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJG2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDKZ2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28