FDA.reportPublic FDA data

Clinistix Kidney Health Test System

Primary DI
00630414317434
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
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JFYEnzymatic Method, Creatinine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFYEnzymatic Method, CreatinineClinical Chemistry2

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064608573
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JFY2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JFY2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JFY2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
16936983168646DrugTect Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JFY2025-02-13
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JFY2024-06-14
00630414631707Clinistix Kidney Health Test SystemSiemens Healthcare Diagnostics Inc.JFY2024-05-03
00630414610962ADVIA CHEM Ecre3Siemens Healthcare Diagnostics Inc.JFY2022-12-22
00630414306438ADVIA CHEM Ecre3Siemens Healthcare Diagnostics Inc.JFY2022-12-22
17290017272471Minuteful - kidney testHEALTHY.IO LTDJFY2022-11-01
00630414610948Atellica CH ECRE3Siemens Healthcare Diagnostics Inc.JFY2022-09-30
00630414301587Atellica CH ECRE3Siemens Healthcare Diagnostics Inc.JFY2022-09-30
03610230006962Yumizen C1200 Creatinine PAPHORIBA ABX SASJFY2021-06-17
00811727016072Pointe Creatinine, Enzymatic ReagentHORIBA INSTRUMENTS INCORPORATEDJFY2021-01-30
00630414607962Clinitek Status ConnectorSiemens Healthcare Diagnostics Inc.JFY2020-09-30
20885380175548CARDINAL HEALTHCardinal Health 200, LLCJFY2020-06-30
20885380175562CARDINAL HEALTHCardinal Health 200, LLCJFY2020-06-30
00811727015761Pointe Creatinine Enzymatic on BS480HORIBA INSTRUMENTS INCORPORATEDJFY2020-05-28
07613336121160Creatinine plus ver.2Roche Diagnostics GmbHJFY2020-03-05
10758750031788VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JFY2019-11-13
07070060014630Afinion ACRAbbott Diagnostics Technologies ASJFY2019-05-16
07070060014654Afinion HbA1cAbbott Diagnostics Technologies ASJFY2019-05-16
00386100001995CREA Reagent Kit MEDICA CORPORATIONJFY2019-02-14
00380740136161AlinityABBOTT LABORATORIESJFY2018-08-08
00380740136178AlinityABBOTT LABORATORIESJFY2018-08-08
10673486000573TECO DIAGNOSTICSTECO DIAGNOSTICSJFY2018-02-12
00630414595795Atellica CH ECre_2Siemens Healthcare Diagnostics Inc.JFY2017-12-22