FDA.reportPublic FDA data

U-Catch

Primary DI
06972428161400
Brand
U-Catch
Company
Shenzhen Bioeasy Biotechnology Co., Ltd
Model
U-Catch Urine Collection Cup
Catalog number
YRLG28901025
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
JJWUrinalysis Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJWUrinalysis Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972428161400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972428161400069724281614006972428161400

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse 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 multiple drugs of abuse 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
Premarket exempt
true
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
06972428160816U-CatchU-Catch Marijuana Test Dip Card 20YRLG068040052022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750653Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750660Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750677Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750684Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750691Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750707Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750714Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750721Urinalysis ControlUrit Medical Electronic Co., Ltd.JJW2026-04-16
00682607200672Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200689Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200696Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200702Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
20682607200676Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200683Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200690Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200706Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
07290012140136QwikCheck BeadsM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
07290012140600QwikCheck Beads Proficiency and Training KitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
07290016650020QwikCheck Beads Precision and Linearity kitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
00896863002424Chromascopics Control Level 1&2 Set 2x25mL (International)QUANTIMETRIX CORPORATIONJJW2023-05-04
04987562408528UF II CONTROLSYSMEX CORPORATIONJJW2022-11-30
04987562433469UC CONTROLSYSMEX CORPORATIONJJW2022-11-30
04987562433681UF-CONTROLSYSMEX CORPORATIONJJW2022-11-30
05055273207583URINALYSIS CONTROL - LEVEL 1 (URNAL CONTROL 1)RANDOX LABORATORIES LIMITEDJJW2022-10-05
05055273207590URINALYSIS CONTROL - LEVEL 2 (URNAL CONTROL 2)RANDOX LABORATORIES LIMITEDJJW2022-10-05
00850015517198SiemensKOVA INTERNATIONAL, INC.JJW2022-03-03
00850015517204SiemensKOVA INTERNATIONAL, INC.JJW2022-03-03
00850015517211SiemensKOVA INTERNATIONAL, INC.JJW2022-03-03
00847661000549LiquichekBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661000556LiquichekBIO-RAD LABORATORIES, INC.JJW2020-09-14