FDA.reportPublic FDA data

Accustrip Urine Reagent Strip Reader

Primary DI
10763924850508
Brand
Accustrip Urine Reagent Strip Reader
Company
JANT PHARMACAL CORPORATION
Model
UA850
Device description
Urine Reagent Strip Reader For Use With Accustrip URS 10 Urine Reagent Strips. *CLIA-Waived*
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K061742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061742000URYXXON RELAX URINE ANALYZERMacherey-Nagel GmbH & Co. KG2006-09-06JIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10763924850508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1076392485050810763924850508

GMDN Terms#

Term, Definition table
TermDefinition
Urine catalase IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for catalase within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
797393659
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10763924750044Accutest H. Pylori Urease Rapid Test ID7502026-04-21
10763924601568ACCUTEST Uriscreen Rapid Screen for UTI. TestID6012016-09-24
00763924540105LipidPlus® Glucose Test StripsMD5402017-02-16
10763924532107LipidPlus® Total Cholesterol Test StripsMD5322017-02-16
10763924550507LipidPlus® MeterMD5502017-02-16
10763924851109Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived)PF8512016-09-20
10763924853202Accutest VALUE+™ hCG Urine Pregnancy Test Cassette (CLIA Waived)PF8532016-09-20
10763924864208Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine)PF8642016-09-20
10763924320919Accutest CLEAR MDMA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitDS3202016-09-20
10763924095213Accutest Breath Alcohol DetectorDS95AC2202016-09-24
10763924097224Accustrip Saliva Alcohol TestDS97AC1252016-09-24
10763924210142AccutestUA702A2016-09-24
10763924410146AccutestUA704A2016-09-24
10763924710147AccutestUA710A2016-09-24
10763924870100Accustrip 10-Parameter Urine Reagent Strip UA870007639248701032016-09-24
10763924319913Accutest CLEAR Marijuana/THC Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitDS3192016-09-20
20763924897104Accustrip URS Strips + ReaderUA8972016-09-24
10763924309914Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitDS3092016-09-20
10763924310910Accutest CLEAR Oxycodone Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitDS3102016-09-20
10763924311917Accutest CLEAR Amphetamine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitDS3112016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIL2026-04-16
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06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-04-16
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20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
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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
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