FDA.reportPublic FDA data

Pocguide Multi-Drug Test Cup OTC

Primary DI
06978151200119
Brand
Pocguide Multi-Drug Test Cup OTC
Company
Hangzhou Aichek Medical Technology Co., Ltd.
Model
1
Device description
Pocguide Multi-Drug Test Cup OTC (CLIA Waived), 12-Panel, 25T/Box;AMP500/BAR300/BUP10/BZO300/COC150/MET500/MDMA500/MTD300/MOP300/OXY100/PCP25/THC50
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NFTTest, Amphetamine, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242077000PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test CupAicheck Biotech, Inc.2024-08-14NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06978151200119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978151200119069781512001196978151200119

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
548416054
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
10648564316280SnapCheckDx Rapid Urine THC Test12026-05-12
06978151200102Pocguide Multi-Drug Test Cup12026-05-06
06978151200126Pocguide Multi-Drug Test Panel12026-05-06
06978151200133Pocguide Multi-Drug Test Panel OTC12026-05-06
06978151200003Pocguide Multi-Drug Test Cup12024-12-24
06978151200010Pocguide Multi-Drug Test Panel12024-12-24
06978151200027Pocguide Multi-Drug Test Cup12024-12-24
06978151200034Pocguide Multi-Drug Test Panel12024-12-24
06978151200041Pocguide Multi-Drug Test Cup12024-12-24
06978151200058Pocguide Multi-Drug Test Panel12024-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNFT2026-08-14
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500293OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500309OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500316OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500323OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500330OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500347OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500354OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500361OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500378OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500385OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500392OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500408OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500415OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500422OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500439OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500446OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500453OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11