Pocguide Multi-Drug Test Cup OTC

Primary DI
06978151200294
Brand
Pocguide Multi-Drug Test Cup OTC
Company
Hangzhou Aichek Medical Technology Co., Ltd.
Model
25 tests/kit
Device description
14 in 1, AMP1000/BUP10/BAR300/BZO300/COC300/EDDP300/MET1000/MDMA500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50
Published
2026-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NFTTest, Amphetamine, Over The Counter
NFVTest, Benzodiazepine, Over The Counter
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter
NGMTest, Phencyclidine (Pcp), Over The Counter
PTGTest, Methadone, Over The Counter
PTHTest, Barbiturate, Over The Counter
QAWTest, Tricyclic Antidepressants, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU
PTGTest, Methadone, Over The CounterClinical Toxicology2
PTHTest, Barbiturate, Over The CounterClinical Toxicology2
QAWTest, Tricyclic Antidepressants, 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
06978151200294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978151200294069781512002946978151200294

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 Temperature00

Regulatory Flags#

DUNS number
548416054
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978151200195HCG One Step Pregnancy Test Midstream OTC1 test/kit2026-10-27
06978151200263HCG One Step Pregnancy Test Strip Rx50 tests/kit2026-10-27
06978151200270HCG One Step Pregnancy Test Midstream Rx1 test/kit2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTC25 tests/kit2026-10-27
06978151200201HCG One Step Pregnancy Test Strip OTC50 tests/kit2026-10-23
10648564316280SnapCheckDx Rapid Urine THC Test12026-05-12
06978151200102Pocguide Multi-Drug Test Cup12026-05-06
06978151200119Pocguide Multi-Drug Test Cup OTC12026-05-06
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
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NFW2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NGM2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.PTG2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NGG2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NFY2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NFV2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.PTH2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NGL2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NFT2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.QAW2026-10-27
00311917077932WalgreensWALGREEN CO.NFW2026-10-14
00311917077932WalgreensWALGREEN CO.NGG2026-10-14
00311917077932WalgreensWALGREEN CO.NGL2026-10-14
00311917077932WalgreensWALGREEN CO.NFY2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.PTH2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.QAW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGG2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.PTG2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFV2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.PTG2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFV2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.PTH2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14