FDA.reportPublic FDA data

CLIAwaived

Primary DI
00816610020181
Brand
CLIAwaived
Company
Cliawaived, Inc.
Model
CLIA-SDDT-16
Catalog number
CLIA-SDDT-16
Device description
Single Drug Dipstick Test for MET500
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
DJCThin Layer Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJCThin Layer Chromatography, MethamphetamineClinical 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
00816610020181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816610020181008166100201818166100201810816610020181

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine/methamphetamine group 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 the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy] 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. It is not intended for self-testing.

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
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
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDJC2023-04-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-05-28
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJC2020-06-18
10722066005139Rapid ResponseBTNX IncDJC2020-06-03
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2020-05-29
10722066005108Rapid ResponseBTNX IncDJC2020-02-12
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDJC2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2019-02-12
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-07-05
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-05-23
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-02-13
10694644300663RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644300670RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644300649RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-04-06
10694644300656RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-04-06