FDA.reportPublic FDA data

McKesson

Primary DI
10612479197463
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
121-6OB
Device description
STRIP, F/URINE TEST 60B (100/V
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
20612479197477PackageGS11In Commercial Distribution
40612479197488PackageGS112In Commercial Distribution
10612479197463PrimaryGS10
00612479218581Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061247919747720612479197477
4061247919748840612479197488
1061247919746310612479197463
00612479218581006124792185816124792185810612479218581

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, colorimetric dipstick, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick (strip) method. This test is 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].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
20682607610031Mission Urinary Tract Infection (UTI) Test stripsACON LABORATORIES, INC.LJX2025-05-12
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
06974246461359URINARY TRACT INFECTION TESTSafecare Biotech (Hangzhou) Co., Ltd.LJX2024-05-11
08806141303497One+Step 10ADFI CO.,LTDLJX2023-10-16
08806141303480One+Step UTIDFI CO.,LTDLJX2023-10-14
06973848670008MetricJilin Test BIO-Electron Co.,LtdLJX2022-12-27
10810038631445Easy@Home Urinary Tract Infection Test Strips (10 Pack)EASY HEALTHCARE CORPORATIONLJX2022-02-17
00810038633473Easy@Home Urinary Tract Infection Test Strips (20 Pack)EASY HEALTHCARE CORPORATIONLJX2022-02-17
00075537171523Chemstrip 2 LN Test StripsRoche Diagnostics GmbHLJX2021-01-18
00850024942073StixGet Stix Inc.LJX2020-10-01
00860002060484StixGet Stix Inc.LJX2020-10-01
00023513000039TopCareREESE PHARMACEUTICAL COMPANYLJX2020-08-14
50885380175556CARDINAL HEALTHCardinal Health 200, LLCLJX2020-06-30
00023513487441DG HealthREESE PHARMACEUTICAL COMPANYLJX2020-06-01
20682607651003HealthyMe UTI Urinary Tract Infection Test StripsACON LABORATORIES, INC.LJX2020-04-30
00722066001936Rapid ResponseBTNX IncLJX2019-10-16
10673486000429TECO DIAGNOSTICSTECO DIAGNOSTICSLJX2018-01-19
10673486000443TECO DIAGNOSTICSTECO DIAGNOSTICSLJX2018-01-19
10673486000412TECO DIAGNOSTICSTECO DIAGNOSTICSLJX2017-01-05
10607415001294Moore MedicalMOORE MEDICAL LLCLJX2016-12-09