FDA.reportPublic FDA data

HairCheck-DT (Cocaine)

Primary DI
00868586000216
Brand
HairCheck-DT (Cocaine)
Company
Quest Diagnostics
Model
K152232
Device description
HairCheck-DT (Cocaine) is an ELISA test kit used for qualitative detection of Cocaine in head hair with a cutoff of 300 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.
Published
2016-12-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152232000Quest Diagnostics HairCheck-DT (Cocaine)Quest Diagnostics Incorporated2016-11-18DIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868586000216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868586000216008685860002168685860002160868586000216

GMDN Terms#

Term, Definition table
TermDefinition
Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cocaine and/or cocaine metabolites in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
189222334
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054552136K-QUE-ACT-001-PRK-QUE-ACT-001-PR2026-05-01
00850054552068K-QUE-ACT-001 REV002K-QUE-ACT-001 REV0022026-02-25
00850054552075K-QUE-ACT-003 REV002K-QUE-ACT-003 REV0022026-02-25
00850054552082K-QUE-ACT-004 REV002K-QUE-ACT-004 REV0022026-02-25
00850054552099K-QUE-ACT-005 REV002K-QUE-ACT-005 REV0022026-02-25
00850054552105K-QUE-ACT-006 REV001K-QUE-ACT-006 REV0012026-02-25
00850054552112K-QUE-ACT-007 REV000K-QUE-ACT-007 REV0002026-02-25
00850054552129K-QUE-KED-001 REV000K-QUE-KED-001 REV0002026-02-25
00850054552037US Blood And Urine KitExempt2024-05-01
00810121520000Blood Specimen Collection Kit (EPH)Exempt2023-08-23
00868586000247HairCheck-DT (THC)K0402572016-09-23
10869419000219Express ResultsTMUDOA-10CA-0503-01 2016-09-24
00850054552044US Paramed Collection Oral Fluid KitExempt2024-05-01
00850054552051US Urine Examiner KitExempt2024-05-01
10850054552034US Blood And Urine KitExempt2024-05-01
10850054552041US Paramed Collection Oral Fluid KitExempt2024-05-01
10850054552058US Urine Examiner KitExempt2024-05-01
00868586000292Quest Diagnostics Oral Fluid Oxycodone HEIAPVH-Exempt2017-10-02
00850054552013US Agent Collection Oral Fluid KitExempt2024-01-15
10869419000202Express ResultsTM UDOA-6CA-0503-012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDIO2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDIO2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDIO2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDIO2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDIO2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2019-02-12