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

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) 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.

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

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Primary DI, Brand, Company table
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10694644300779RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10722066005139Rapid ResponseBTNX IncLDJ2020-06-03
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2020-05-29
10763924935632Accutest JANT PHARMACAL CORPORATIONLDJ2019-03-05
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10694644300755RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-07-05
10694644500391RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLDJ2018-06-20
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-05-23
10722355002573Detector Drug CupImmunostics Company, IncLDJ2018-05-21
10722355002580Detector Drug CupImmunostics Company, IncLDJ2018-05-21
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-04-19
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10694644300694RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-03-23
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