FDA.reportPublic FDA data

CLIAwaived

Primary DI
00816610020822
Brand
CLIAwaived
Company
Cliawaived, Inc.
Model
CLIA-IDTC-5-60527a
Catalog number
CLIA-IDTC-5-60527a
Device description
CLIAwaived,Inc. IDTC- 5 Panel Cup with Adulterants (CR, SG, OX) (COC 300,MET 1000,OPI 300, OXY 100, THC 50)-(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
DJGEnzyme Immunoassay, Opiates
LAFGas Chromatography, Methamphetamine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
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
00816610020822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816610020822008166100208228166100208220816610020822

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
00816610020808CLIAwaivedCLIA-IDTC-12BUPaCLIA-IDTC-12BUPa2016-10-26
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 CompanyDIO2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyLAF2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJG2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyLDJ2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
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
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28