FDA.reportPublic FDA data

U-Catch

Primary DI
06972428160816
Brand
U-Catch
Company
Shenzhen Bioeasy Biotechnology Co., Ltd
Model
U-Catch Marijuana Test Dip Card 20
Catalog number
YRLG06804005
Published
2022-12-08
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
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192515000BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20Shenzhen Bioeasy Biotechnology Co., Ltd.2019-10-11LDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972428160816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972428160816069724281608166972428160816

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
06972428160809U-CatchU-Catch PLUS Multi-Drug Test CupYRLG025010052022-12-08
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
06972428160823U-CatchU-Catch Marijuana Test Dip Card 20YRLG068040252022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCLDJ2026-10-30
B115SCDCARD01THC501SnapCheckDx Multi-Drug Screen Test DipcardADVIN BIOTECH, INC.LDJ2026-10-30
00894175000091QMedix™Diagnostic Automation, Inc.LDJ2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-09-24
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyLDJ2026-07-31
00841824104167ECOIIW.H.P.M. INC.LDJ2026-07-07
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyLDJ2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28