FDA.reportPublic FDA data

FirstCheck HOME DRUG TEST

Primary DI
06936983177689
Brand
FirstCheck HOME DRUG TEST
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
1
Device description
REF: ABTDOAO17701A, FDA OTC, 1T/kit, AMP500/COC150/FYL1/MDMA500/MET500/MOP300/THC50
Published
2025-02-14
Public version status
Update
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
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K244043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K244043000AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.2025-02-27NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936983177689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936983177689069369831776896936983177689

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543254717
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50045611956013ept Pregnancy (hCG) Enhanced Sensitivity Rapid Test Midstream (Urine)1FHC-AU103H2026-10-29
50045611956044ept Digital Early Pregnancy Test Midstream(Urine)1FHC-AEU103H2026-10-29
00045611956049ept Digital Early Pregnancy Test Midstream(Urine)1FHC-AEU103H2026-10-27
00045611951013ept Pregnancy (hCG) Rapid Test Midstream (Urine)1FHC-A103H2026-10-26
06942598249376One Step® Fentanyl(FYL1) Urine Test Panel1DFY-A114H2026-10-12
06942598249383One Step® Buprenorphine (BUP10) Home Rapid Test Dipstick1DBU-A101H2026-10-12
06942598249390One Step® Benzodiazepines (BZO300) Home Rapid Test Dipstick1DBZ-A101H2026-10-12
06942598249406One Step® Methamphetamine (MET500) Home Rapid Test Dipstick1DME-A101H2026-10-12
06942598249413One Step® Methadone (MTD300) Home Rapid Test Dipstick1DMT-A101H2026-10-12
06942598249420One Step® Morphine (MOP/OPI2000) Home Rapid Test Dipstick1DOP-A101H2026-10-12
16936983131633Multi-Drug Rapid Test Panel (Urine)1DOA-A1104C2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)1DOA-A1124C2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test Cup1DOA-A1127C-062-b-A32026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test Cup1DUA-A1127C-A32026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test Cup1DUA-A1127C-A32026-04-16
16936983144664DiscoverDISP-CUP164N$2023-11-30
16936983144671DiscoverDISP-DUD6144N$2023-11-30
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)1DOA-A1107C-A32026-04-16
16936983149744Discover milti-drug 7 drugs rapid test cupDUA-A177C-A3 A1617DISP-DUD774N$2024-02-08
16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)1DUA-A1137C-A32026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G754QTUCUP10BU1QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFY2026-10-30
G754QTUCUP10BU1QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NGL2026-10-30
G754QTUCUP10BU1QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFT2026-10-30
G754QTUCUP10BU1QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NGG2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFT2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFY2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NGG2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NGL2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFW2026-10-30
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.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.NGL2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NFT2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.NGG2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.NFT2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.NGL2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.NFY2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.NFW2026-10-27
00311917077932WalgreensWALGREEN CO.NGL2026-10-14
00311917077932WalgreensWALGREEN CO.NFY2026-10-14
00311917077932WalgreensWALGREEN CO.NGG2026-10-14
00311917077932WalgreensWALGREEN CO.NFW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGG2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14