FDA.reportPublic FDA data

U-Catch

Primary DI
06972428160809
Brand
U-Catch
Company
Shenzhen Bioeasy Biotechnology Co., Ltd
Model
U-Catch PLUS Multi-Drug Test Cup
Catalog number
YRLG02501005
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
NGITest, Morphine, 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
NGITest, Morphine, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193480000BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd.2020-01-31NGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972428160809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972428160809069724281608096972428160809

Regulatory Flags#

DUNS number
547954309
Device count
1
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
06972428162186U-CatchU-Catch Cotinine (COT) Test Dip CardYRLG278010252023-03-09
06972428161820U-CatchU-Catch PLUS Multi-Drug Test Cup BPU255-A3(4)2023-02-16
06972428161813U-Catch U-Catch XR Multi-Drug Test CupBXU2135-A3(4)2023-01-31
06972428161738U-Catch U-Catch PLUS Multi-Drug Test Cup BPU6125-A3(1)2022-12-26
06972428161691U-Catch U-Catch XR Multi-Drug Test Cup2022-12-26
06972428161707U-Catch U-Catch PLUS Multi-Drug Test CupBPU255-A3(1)2022-12-26
06972428161714U-Catch U-Catch PLUS Multi-Drug Test Cup BPU1105-A3(4)2022-12-26
06972428161721U-Catch U-Catch PLUS Multi-Drug Test CupBPU1105-A3(3)2022-12-26
06972428161745U-Catch U-Catch PLUS Multi-Drug Test Cup2022-12-26
06972428161752U-Catch U-Catch PLUS Multi-Drug Test CupBPU1125-A52022-12-26
06972428161769U-Catch U-Catch XR Multi-Drug Test CupBXU8104-A3(1)2022-12-26
06972428161776U-Catch U-Catch PLUS Multi-Drug Test CupBPU155-A3(1)2022-12-26
06972428161783U-Catch U-Catch XR Multi-Drug Test CupBXU8104-A3(4)2022-12-26
06972428161790U-Catch U-Catch XR Multi-Drug Test CupBXU4105-A3(4)2022-12-26
06972428161806U-Catch U-Catch XR Multi-Drug Test Cup2022-12-26
06972428161110U-Catch U-Catch PLUS Multi-Drug Test CupYRLG02801025-32022-12-09
06972428160786U-CatchU-Catch PLUS Multi-Drug Test CupYRLG028010052022-12-08
06972428160793U-CatchU-Catch PLUS Multi-Drug Test CupYRLG027010052022-12-08
06972428160816U-CatchU-Catch Marijuana Test Dip Card 20YRLG068040052022-12-08
06972428160823U-CatchU-Catch Marijuana Test Dip Card 20YRLG068040252022-12-08

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.NFV2026-10-30
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.NFW2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NGG2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFY2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFT2026-10-30
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.NFV2026-10-27
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.NFY2026-10-27
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.NFV2026-10-27
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.NFW2026-10-27
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.NFV2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFV2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14