FDA.reportPublic FDA data

Urine Reagent Strips, 1-parameter, ketone

Primary DI
00664816000014
Brand
Urine Reagent Strips, 1-parameter, ketone
Company
LW SCIENTIFIC, INC.
Model
URS-01PR-KE77
Device description
Urine reagent strips; 1-parameter; ketone; 100 strips per vial
Published
2016-09-20
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
JINNitroprusside, Ketones (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003987000URS-1K (KETONE TESST)Teco Diagnostics2001-04-26JIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00664816000014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00664816000014006648160000146648160000140664816000014

GMDN Terms#

Term, Definition table
TermDefinition
Urine ketone 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 ketones 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
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
00816042016417FORAFORA CARE INC.JIN2026-03-20
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
04710469879548XPER Technology Multi-Functional Monitoring System Procheck SmartTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
04710469879555XPER Technology Multi-Functional Monitoring System Procheck WittyTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
04719893233841XPER Technology Procheck Witty Procheck Smart B-Ketone Test StripsTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
00850014861681heartscare B-Ketone Test Strips (10pcs/Box)Hearts Bio, Inc.JIN2025-10-01
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
00850014861575HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-07-02
00850014861056HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-03-31
00816042015199FORAFORA CARE INC.JIN2025-03-14
00850054026729QMedix™Diagnostic Automation, Inc.JIN2024-10-29
00816042015069FORAFORA CARE INC.JIN2024-10-01
00816042015076FORAFORA CARE INC.JIN2024-10-01
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIN2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-05