U-Catch

Primary DI
06972428160830
Brand
U-Catch
Company
Shenzhen Bioeasy Biotechnology Co., Ltd
Model
U-Catch Marijuana Test Dip Card 40
Catalog number
YRLG06806025
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
06972428160830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972428160830069724281608306972428160830

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
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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
06972428160816U-CatchU-Catch Marijuana Test Dip Card 20YRLG068040052022-12-08

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