FDA.reportPublic FDA data

Urine Reagent Strips, 1-parameter, glucose

Primary DI
00664816000069
Brand
Urine Reagent Strips, 1-parameter, glucose
Company
LW SCIENTIFIC, INC.
Model
URS-01PR-GL77
Device description
Urine reagent strips; 1-parameter; glucose; 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
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942648000IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SETTeco Diagnostics1995-03-24JIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00664816000069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00664816000069006648160000696648160000690664816000069

GMDN Terms#

Term, Definition table
TermDefinition
Urine glucose 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 glucose 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
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIL2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIL2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
00015482104658AUTION MAX™ AX-4060 AnalyzerARKRAY USA, INC.JIL2025-11-07
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIL2025-09-18
00015482117313AUTION MAX™ AX-4060 AnalyzerARKRAY USA, INC.JIL2024-12-02
00850054026729QMedix™Diagnostic Automation, Inc.JIL2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIL2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIL2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIL2024-06-04
10673486002416Teco Diagnostics Urine Reagent Strips (URS-1G)TECO DIAGNOSTICSJIL2024-03-22
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JIL2023-06-08
10888277720336MedlineMEDLINE INDUSTRIES, INC.JIL2022-12-10
10884389181966MedlineMEDLINE INDUSTRIES, INC.JIL2022-10-28
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10884389181973MedlineMEDLINE INDUSTRIES, INC.JIL2022-04-13
10884389181959MedlineMEDLINE INDUSTRIES, INC.JIL2021-09-16
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