FDA.reportPublic FDA data

Clinistix UTI Test Strips

Primary DI
00630414631677
Brand
Clinistix UTI Test Strips
Company
Siemens Healthcare Diagnostics Inc.
Model
11643375
Catalog number
11643375
Device description
Test strips for urinary tract infection
Published
2024-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JMTDIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
LJXTEST, URINE LEUKOCYTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
LJXTest, Urine LeukocyteHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960888000CHEK-STIX U.T.I. SELF-TESTBayer Corp.1996-07-05JMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414631677PrimaryGS10
00630414317427Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414631677006304146316776304146316770630414631677
00630414317427006304143174276304143174270630414317427

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes 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 to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00Store Upright
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16936983169605Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.JMT2026-04-15
16936983186893DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-14
16936983192887Alltest Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983192894Alltest Multi-Drug 16 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983192900Alltest Multi-Drug 18 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197257Multi-Drug 8 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197264Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197271Multi-Drug 14 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16942598200619Multi-Drug 9 Drugs Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16942598203795DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-08
16942598203795DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.LJX2026-04-08
00677421450013NEW CHOICESCI Medic, Inc.JMT2026-03-26
00677421450013NEW CHOICESCI Medic, Inc.LJX2026-03-26
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JMT2026-02-06
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JMT2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JMT2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.LJX2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JMT2025-09-18
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSLJX2024-06-06
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJMT2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJMT2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSLJX2024-06-04
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJMT2024-06-04
08806141303497One+Step 10ADFI CO.,LTDJMT2023-10-16
08806141303480One+Step UTIDFI CO.,LTDJMT2023-10-14
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JMT2023-06-08