FDA.reportPublic FDA data

Urine Reagent Strips, 5-parameter

Primary DI
00664816000045
Brand
Urine Reagent Strips, 5-parameter
Company
LW SCIENTIFIC, INC.
Model
URS-05PR-7777
Device description
Urine reagent strips; 5-parameter; 100 strips per vial
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
CENDye-Indicator, Ph (Urinary, Non-Quant.)
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
JINNitroprusside, Ketones (Urinary, Non-Quant.)
JIOBlood, Occult, Colorimetric, In Urine
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970250000CLINISTRIPTeco Diagnostics1997-04-08JIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00664816000045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00664816000045006648160000456648160000450664816000045

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
785335381
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00664816005897Qor LabsQLL-HRSD-10T3QLL-HRSD-10T32026-04-20
00664816005903Qor LabsQLL-HRDD-20T3QLL-HRDD-20T32026-04-20
00664816005316LW Scientific, Inc.Z4M-BZM7-EML3Z4M-BZM7-EML32026-04-17
00664816005323LW Scientific, Inc.Z4M-TZM7-EML3Z4M-TZM7-EML32026-04-17
00664816006030LW Scientific, Inc`E8C-C8AF-150PE8C-C8AF-150P2026-03-02
00664816006016LW ScientificM5C-BKT8-50A1M5C-BKT8-50A12026-02-20
00664816002322LW Scientific, IncICL-030L-D101ICL-030L-D1012026-02-19
00664816005682LW Scientific, Inc.MUC-08AT-15T3MUC-08AT-15T32026-02-16
00664816005699LW Scientific, Inc.DBL-40PL-02DPDBL-40PL-02DP2026-02-16
00664816005866LW Scientific, Inc.ROM-BN4A-IPL3ROM-BN4A-IPL32025-10-20
00664816005873LW Scientific, Inc.ELM-BN4A-IPL3ELM-BN4A-IPL32025-10-20
00664816005934LW Scientific, Inc.ROM-TN4A-IPL3ROM-TN4A-IPL32025-10-20
00664816005941LW Scientific, Inc.ELM -TN4A-IPL3ELM -TN4A-IPL32025-10-20
00664816005958LW Scientific, Inc.ASM-BN4A-IPL3ASM-BN4A-IPL32025-10-20
00664816005965LW Scientific, Inc.ASM-TN4A-IPL3ASM-TN4A-IPL32025-10-20
00664816001400LW Scientific, Inc.SHL-PPF7-06F1SHL-PPF7-06F12021-04-09
00664816003756LW Scientific, Inc`MMC-12MD-02T1MMC-12MD-02T12024-07-01
00664816005842LW Scientific, Inc.FWL-TISS-BTH3FWL-TISS-BTH32024-06-28
00664816005835LW ScientificZIC-06AD-15P3ZIC-06AD-15P32024-06-13
00664816001431LW Scientific, Inc.WBL-20LC-SSD1WBL-20LC-SSD12021-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.CEN2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIR2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIO2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIL2024-06-05
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIO2024-06-05
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSCEN2024-06-05
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSCEN2024-06-04
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-04
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIR2024-06-04
08806141303497One+Step 10ADFI CO.,LTDJIN2023-10-16
08806141303497One+Step 10ADFI CO.,LTDCEN2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJIR2023-10-16
08806141303480One+Step UTIDFI CO.,LTDCEN2023-10-14
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIR2020-09-22
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.,LTDCEN2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIL2020-09-22
08806141302070CYBOW 10DFI CO.,LTDJIL2020-06-29
08806141302070CYBOW 10DFI CO.,LTDJIN2020-06-29
08806141302070CYBOW 10DFI CO.,LTDJIR2020-06-29
08806141302070CYBOW 10DFI CO.,LTDCEN2020-06-29
08806141301998Yodoc 10DFI CO.,LTDJIR2020-02-20
08806141301998Yodoc 10DFI CO.,LTDJIO2020-02-20
08806141301998Yodoc 10DFI CO.,LTDJIN2020-02-20
08806141301998Yodoc 10DFI CO.,LTDCEN2020-02-20
10301932880508KETOSTIX®ASCENSIA DIABETES CARE US INC.JIN2019-06-06
10301932881215KETOSTIX®ASCENSIA DIABETES CARE US INC.JIN2019-06-06