FDA.reportPublic FDA data

Personal Care

Primary DI
00808829121612
Brand
Personal Care
Company
DELTA BRANDS INC.
Model
Cassette
Device description
Cannabinoid test is an in vitro diagnostic test for the qualitative analysis of cannabinoids for employment and insurance testing.This Reagent, the Marijuana(THC) Rapid Test Cassette detects 11-nor-Delta9-THC-9-COOH in urine at concentrations equal to or greater than 50 ng/ml. The Marijuana (THC) Test is a rapid qualitative competitive binding immunoassay for determination of Marijuana in urine.
Published
2022-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PVJTest, Cannabinoid, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVJTest, Cannabinoid, Employment And Insurance Testing, ExemptClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00808829121612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00808829121612008088291216128088291216120808829121612

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid/cannabinoid metabolite IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen.

Regulatory Flags#

DUNS number
102672008
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00808829131185Lucky Super SoftLarge Plastic Bandages2026-04-10
00808829130980Lucky Super SoftExtra Large Plastic Bandages2026-03-27
00808829130706Lucky Super SoftFlex Fabric Bandages2026-02-13
00808829129083Lucky Super SoftExtra Large Plastic Bandages2025-07-09
00808829127065Lucky Super SoftBandages in differenet size2024-05-10
00808829125672CLARISSETest midstream I2024-03-07
00808829124170Lucky Super SoftBandages In Different Size2023-08-25
00048155920200Personal CareCassette2018-05-11
00808829120615ClarisseMidstream2022-03-25
00808829120028Personal Care120022021-08-27
00808829111903ClarisseCassette2017-11-17
00808829120325Lucky Super SoftBandages in different sizes2023-02-17
00808829119695Lucky Super SoftBandages in differenet size2022-12-16
00808829041002Lucky Super SoftBandages in differenet size2022-12-13
00808829102536Lucky Super SoftKit2022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVJ2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVJ2026-04-29
B29880502EI0DrugCheck Express Diagnostic Int'l, Inc.PVJ2026-02-20
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVJ2026-01-29
00810174470963PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-05
00810174471007PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-05
00810174471182SAFElife™WONDFO USA CO., LTD.PVJ2025-12-05
00810174471212PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-05
00810174471144PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-03
00810174471168PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-03
G474M3209010VerifyMlife Diagnostics, LLCPVJ2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPVJ2025-07-21
00816862026634Prime ScreenWONDFO USA CO., LTD.PVJ2025-07-03
G474M3106010ClassicMlife Diagnostics, LLCPVJ2025-06-20
G474MC002080001EI0ClassicMlife Diagnostics, LLCPVJ2025-03-19
06977469280080U-Catch Marijuana Multi-Level Drug Test Card(Colloidal Gold)Eterbio, Inc.PVJ2024-12-18
06977469280219S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.PVJ2024-12-18
G474MC001050002EI0ClassicMlife Diagnostics, LLCPVJ2024-11-05
G474MV002110001EI0VerifyMlife Diagnostics, LLCPVJ2024-10-08
00850054867704AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-30
00850054867711AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-30
00850054867728AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-30
00850054867735AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-30
00850054867896AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00850054867964AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00850054867773AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00850054867797AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00850054867803AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00383173000252MGC HEALTHGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-27
00850054867100AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-27