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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXAKit, Screening, Urine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXAKit, Screening, UrineMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K882211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K882211000URISCREENDiatech Diagnostica , Ltd.1988-09-30JXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10763924601568PrimaryGS10
00763924601561Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076392460156810763924601568
00763924601561007639246015617639246015610763924601561

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height3Inch
Length8.38Inch
Weight0.45Pound
Width3.38Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit82 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)676-5565info@jantdx.com

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 DIBrandModelCatalogPublished
10763924750044Accutest H. Pylori Urease Rapid Test ID7502026-04-21
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
10763924850508Accustrip Urine Reagent Strip ReaderUA8502016-09-24
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
07290006418111DIASLIDE URINE CULTURING DEVICESAVYON DIAGNOSTICS LTDJXA2026-05-04
07290013348531URISCREEN SAVYON DIAGNOSTICS LTDJXA2026-04-29
50885380070271CARDINAL HEALTHCardinal Health 200, LLCJXA2024-02-28
00860008737359Know Rapid STD TestMobiLab Medical Innovatives Inc.JXA2024-02-06
00860008737304MobiLab Standard Sexual Health Self Rapid TestMobiLab Medical Innovatives Inc.JXA2024-02-05
00613647003596FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003602FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003619FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003626FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003633FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003640FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003657FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003664FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003701FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003718FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003590FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003606FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003613FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003620FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003637FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003644FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003651FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003668FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003695FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003705FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003712FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
03573026600389CHROMID® CPS® Elite Agar (CPSE)BIOMERIEUX SAJXA2020-05-19
03573026600402CHROMID® CPS® Elite Agar (CPSO)BIOMERIEUX SAJXA2020-05-19
03573026600426CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep bloodBIOMERIEUX SAJXA2020-05-19
03573026443900CHROMID® CPS® Elite Agar (CPSE)BIOMERIEUX SAJXA2020-05-19