FDA.reportPublic FDA data

Metric

Primary DI
16973848670005
Brand
Metric
Company
Jilin Test BIO-Electron Co.,Ltd
Model
50pcs/bottle
Published
2022-12-27
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
LJXTest, Urine Leukocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJXTest, Urine LeukocyteHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973848670005PrimaryGS10
06973848670008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697384867000516973848670005
06973848670008069738486700086973848670008

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
412473487
Device count
50
Premarket exempt
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973848670008Metric50pcs/bottle2022-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.LJX2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.LJX2026-04-16
16942598203795DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.LJX2026-04-08
06942598204542Alltest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.LJX2026-04-08
06942598216781Alltest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.LJX2026-04-08
00677421450013NEW CHOICESCI Medic, Inc.LJX2026-03-26
00810164510624Atida Urinary Tract Infection TestACESO LABORATORIES INC.LJX2026-03-23
06974246462936Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462943Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462950Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462967Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462974Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462981Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
00860015215833Vivoo At-Home UTI Test StripsVIVOSENS INC.LJX2026-02-13
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.LJX2025-09-18
06974246462363T Testahead URINARY TRACT INFECTION TESTSafecare Biotech (Hangzhou) Co., Ltd.LJX2025-07-07
06974246462370T Testahead URINARY TRACT INFECTION TESTSafecare Biotech (Hangzhou) Co., Ltd.LJX2025-07-07
00682607003433Mission Urinary Tract Infection (UTI) Test stripsAcon Laboratories, Inc.LJX2025-05-12
20682607610031Mission Urinary Tract Infection (UTI) Test stripsACON LABORATORIES, INC.LJX2025-05-12
00846036009774GOODSENSEGEISS, DESTIN & DUNN, INCLJX2025-01-16
00860011489122Vivoo At-Home Urinary Tract Infection TestVIVOSENS INC.LJX2024-11-25
00850054026729QMedix™Diagnostic Automation, Inc.LJX2024-10-29
06974246461663Welcheck URINARY TRACT INFECTION TESTSafecare Biotech (Hangzhou) Co., Ltd.LJX2024-10-16
06974246461670Welcheck URINARY TRACT INFECTION TESTSafecare Biotech (Hangzhou) Co., Ltd.LJX2024-10-16
06971257037177urinalysis stripsWeihai Kangzheng Medical Equipment Technology Co., LtdLJX2024-06-22
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2024-06-14