FDA.reportPublic FDA data

CONTEC

Primary DI
06945040104780
Brand
CONTEC
Company
Contec Medical Systems Co., Ltd.
Model
URS-11T
Device description
Urinalysis Strips
Published
2019-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
CENDye-Indicator, Ph (Urinary, Non-Quantitative)
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
JINNitroprusside, Ketones (Urinary, Non-Quant.)
JIOBlood, Occult, Colorimetric, In Urine
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
LJXTest, Urine Leukocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Clinical Chemistry1
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1
JIOBlood, Occult, Colorimetric, In UrineHematology2
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)Clinical Chemistry1
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)Clinical Chemistry1
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
LJXTest, Urine LeukocyteHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945040104780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945040104780069450401047806945040104780

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 method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529606295
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945040101505CONTECPM102016-09-24
06945040113850CONTECNE-M03F2025-10-13
06945040110637CONTECNE-M032025-08-12
06945040106135CONTECSC112021-08-23
06945040106142CONTECSC122021-08-23
06945040106159CONTECSC212021-08-23
06945040106197CONTECSRP12024-11-11
06945040104353NOVAPO-3012017-06-07
06945040105237TytoCare Pulse OximeterCMS50DA+2020-11-11
06945040105251TytoCare Pulse OximeterCMS50DA+2020-11-11
06945040105824CONTECCMS50L-Pro2021-07-26
06945040105794CONTECCMS50-Pro2021-05-31
06945040100171CONTECCMS50DL12016-09-24
06945040100188CONTECCMS50D2016-09-24
06945040100638CONTECCMS50D+2016-09-24
06945040100799CONTECCMS50DL2016-09-24
06945040100829CONTECCMS50EL2016-09-24
06945040104421CONTECPM102017-06-13
06945040104513CONTECCMS50DA2018-04-13
06945040104537CONTECCMS50D1A2018-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIO2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIR2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JMT2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.LJX2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JJB2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.CEN2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.CDM2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JMA2025-09-18
08806141303497One+Step 10ADFI CO.,LTDJIN2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJJB2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJMA2023-10-16
08806141303497One+Step 10ADFI CO.,LTDCDM2023-10-16
08806141303497One+Step 10ADFI CO.,LTDCEN2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJIR2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJMT2023-10-16
08806141303480One+Step UTIDFI CO.,LTDCEN2023-10-14
08806141303480One+Step UTIDFI CO.,LTDJMT2023-10-14
00860010249000Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
00860010249017Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
00860010249024Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDCEN2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIO2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIN2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIL2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIR2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJMT2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJJB2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDLJX2020-09-22
08806141302070CYBOW 10DFI CO.,LTDJJB2020-06-29