FDA.reportPublic FDA data

Clinistix Kidney Health Test System

Primary DI
00630414631707
Brand
Clinistix Kidney Health Test System
Company
Siemens Healthcare Diagnostics Inc.
Model
11643376
Device description
Test Strips for the Determination of Albumin and Creatinine in Urine
Published
2024-05-03
Public version status
New
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
JFYEnzymatic Method, Creatinine
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFYEnzymatic Method, CreatinineClinical Chemistry2
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991315000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991315000MICROALBUSTIX REAGENT STRIPS (OTC)Bayer Corp.1999-11-12JIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414631707PrimaryGS10
00630414317434Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414631707006304146317076304146317070630414631707
00630414317434006304143174346304143174340630414317434

GMDN Terms#

Term, Definition table
TermDefinition
Urine protein 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 protein 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.

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

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
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIR2025-09-18
10884389181942MEDLINEMEDLINE INDUSTRIES, INC.JIR2025-04-29
16936983168646DrugTect Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JFY2025-02-13
16936983168646DrugTect Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JIR2025-02-13
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIR2024-06-04
08806141303497One+Step 10ADFI CO.,LTDJIR2023-10-16
00630414610962ADVIA CHEM Ecre3Siemens Healthcare Diagnostics Inc.JFY2022-12-22
17290017272471Minuteful - kidney testHEALTHY.IO LTDJFY2022-11-01
17290017272471Minuteful - kidney testHEALTHY.IO LTDJIR2022-11-01
00630414610948Atellica CH ECRE3Siemens Healthcare Diagnostics Inc.JFY2022-09-30
10888277677791MedlineMEDLINE INDUSTRIES, INC.JIR2022-08-04
10884389181973MedlineMEDLINE INDUSTRIES, INC.JIR2022-04-13
10884389181959MedlineMEDLINE INDUSTRIES, INC.JIR2021-09-16
00630414607962Clinitek Status ConnectorSiemens Healthcare Diagnostics Inc.JFY2020-09-30
00630414607962Clinitek Status ConnectorSiemens Healthcare Diagnostics Inc.JIR2020-09-30
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIR2020-09-22
10888277110403MedlineMEDLINE INDUSTRIES, INC.JIR2020-08-21
10885380175589CARDINAL HEALTHCardinal Health 200, LLCJIR2020-07-09
20885380175548CARDINAL HEALTHCardinal Health 200, LLCJFY2020-06-30
20885380175548CARDINAL HEALTHCardinal Health 200, LLCJIR2020-06-30
20885380175555CARDINAL HEALTHCardinal Health 200, LLCJIR2020-06-30
20885380175562CARDINAL HEALTHCardinal Health 200, LLCJIR2020-06-30