FDA.reportPublic FDA data

HairCheck-DT Methamphetamine

Primary DI
00868586000278
Brand
HairCheck-DT Methamphetamine
Company
Quest Diagnostics
Model
PVD-Exempt
Device description
HairCheck-DT (Methamphetamine) is an ELISA test kit used for qualitative detection of Methamphetamines in head hair with a cutoff 300 pg/mg of hair. Kit is comprised of 4 Component packages: Microplates, Conjugate Reagents, Common Reagents and Calibrator/Controls.
Published
2018-06-08
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
PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVDTest, Methamphetamine, Employment And Insurance Testing, ExemptClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868586000278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868586000278008685860002788685860002780868586000278

GMDN Terms#

Term, Definition table
TermDefinition
Methamphetamine-specific 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 a specific methamphetamine in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
189222334
Device count
1
Premarket exempt
true
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
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVD2026-04-29
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-03
B29880913EI0DrugCheck Express Diagnostic Int'l, Inc.PVD2026-02-23
B29880502EI0DrugCheck Express Diagnostic Int'l, Inc.PVD2026-02-20
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVD2026-01-29
00810174470963PRIME SCREEN®WONDFO USA CO., LTD.PVD2025-12-05
00810174471007PRIME SCREEN®WONDFO USA CO., LTD.PVD2025-12-05
00810174471182SAFElife™WONDFO USA CO., LTD.PVD2025-12-05
00810174471212PRIME SCREEN®WONDFO USA CO., LTD.PVD2025-12-05
00810174471144PRIME SCREEN®WONDFO USA CO., LTD.PVD2025-12-03
00810174471168PRIME SCREEN®WONDFO USA CO., LTD.PVD2025-12-03
G474M3209010VerifyMlife Diagnostics, LLCPVD2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPVD2025-07-21
00816862026634Prime ScreenWONDFO USA CO., LTD.PVD2025-07-03
G474M3106010ClassicMlife Diagnostics, LLCPVD2025-06-20
G474M3105010ClassicMlife Diagnostics, LLCPVD2025-06-19
00816862026337SAFElife™WONDFO USA CO., LTD.PVD2025-05-19
G474MC002080001EI0ClassicMlife Diagnostics, LLCPVD2025-03-19
06977469280219S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.PVD2024-12-18
G474MC001050002EI0ClassicMlife Diagnostics, LLCPVD2024-11-05
G474MV002110001EI0VerifyMlife Diagnostics, LLCPVD2024-10-08
00850054867704AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-30
00850054867711AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-30
00850054867728AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-30
00850054867735AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-30
00850054867896AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-29
00850054867964AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-29
00850054867773AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-29
00850054867797AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-29