Home GUDID 10763924601568
ACCUTEST Uriscreen Rapid Screen for UTI. Test
Primary DI 10763924601568
Brand ACCUTEST Uriscreen Rapid Screen for UTI. Test
Company JANT PHARMACAL CORPORATION
Model ID601
Device description Rapid Screen for UTI, testing for Bacteriuria and presence of Somatic Cells in Urine.
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true
Product Codes# Code, Name table Code Name JXA Kit, Screening, Urine
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JXA Kit, Screening, Urine Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10763924601568 Primary GS1 0 00763924601561 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10763924601568 10763924601568 00763924601561 00763924601561 763924601561 0763924601561
GMDN Terms# Term, Definition table Term Definition Urine catalase IVD, kit, rapid colorimetric, clinical A 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.
Device Sizes# Type, Value, Unit table Type Value Unit Height 3 Inch Length 8.38 Inch Weight 0.45 Pound Width 3.38 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 50 Degrees Fahrenheit 82 Degrees Fahrenheit
Regulatory Flags# DUNS number 797393659 Device count 20 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10763924750044 Accutest H. Pylori Urease Rapid Test ID750 2026-04-21 00763924540105 LipidPlus® Glucose Test Strips MD540 2017-02-16 10763924532107 LipidPlus® Total Cholesterol Test Strips MD532 2017-02-16 10763924550507 LipidPlus® Meter MD550 2017-02-16 10763924851109 Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived) PF851 2016-09-20 10763924853202 Accutest VALUE+™ hCG Urine Pregnancy Test Cassette (CLIA Waived) PF853 2016-09-20 10763924864208 Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine) PF864 2016-09-20 10763924320919 Accutest CLEAR MDMA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS320 2016-09-20 10763924095213 Accutest Breath Alcohol Detector DS95AC220 2016-09-24 10763924097224 Accustrip Saliva Alcohol Test DS97AC125 2016-09-24 10763924210142 Accutest UA702A 2016-09-24 10763924410146 Accutest UA704A 2016-09-24 10763924710147 Accutest UA710A 2016-09-24 10763924850508 Accustrip Urine Reagent Strip Reader UA850 2016-09-24 10763924870100 Accustrip 10-Parameter Urine Reagent Strip UA870 00763924870103 2016-09-24 10763924319913 Accutest CLEAR Marijuana/THC Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS319 2016-09-20 20763924897104 Accustrip URS Strips + Reader UA897 2016-09-24 10763924309914 Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS309 2016-09-20 10763924310910 Accutest CLEAR Oxycodone Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS310 2016-09-20 10763924311917 Accutest CLEAR Amphetamine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS311 2016-09-20
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