FDA.reportPublic FDA data

ADVIA CHEM Ecre3

Primary DI
00630414306438
Brand
ADVIA CHEM Ecre3
Company
Siemens Healthcare Diagnostics Inc.
Model
11537235
Catalog number
11537235
Device description
Creatinine enzymatic - ADVIA Chem. - RGT
Published
2022-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
K212223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212223000Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc.2021-11-24JFY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414610962PrimaryGS10
00630414306438Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414610962006304146109626304146109620630414610962
00630414306438006304143064386304143064380630414306438

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Keep from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005088112
Device count
4
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
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JFY2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JFY2026-06-26
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
00630414317434Clinistix Kidney Health Test SystemSiemens Healthcare Diagnostics Inc.JFY2024-05-03
00630414610962ADVIA 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