FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740163358
Brand
ARCHITECT
Company
Abbott GmbH
Model
1E47-03
Catalog number
01E4703
Device description
ICT Urine Calibrator
Published
2019-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIXCalibrator, multi-analyte mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740163358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740163358003807401633583807401633580380740163358

GMDN Terms#

Term, Definition table
TermDefinition
Multiple electrolyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811727018977POINTE Chemistry Calibrator SetHORIBA INSTRUMENTS INCORPORATEDJIX2026-05-01
00850083817008Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817015Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817022Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817039Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
00850033167184Smartest Persona II Multi Blood Glucose Monitoring SystemGlobalmed Holdings, LLCJIX2024-12-02
00630414615097Atellica CH Billirubin Calibrator (BILI CAL)Siemens Healthcare Diagnostics Inc.JIX2024-04-03
08430793040761Aptiva® APS IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
00630414611051Atellica CH Prot2 CALSiemens Healthcare Diagnostics Inc.JIX2024-02-02
00852676007063Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2023-08-09
08430793040518Aptiva® Celiac Disease IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
08430793040570Aptiva® Celiac Disease IgA CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
14987481102924Multi Calibrator LipidsFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIX2020-10-23
00380740161378ARCHITECTAbbott GmbHJIX2020-09-18
00817302023213Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2020-05-08
00852676007780Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2020-03-28
00630414284972N Rheumatology Standard SLSiemens Healthcare Diagnostics Products GmbHJIX2020-02-14
04250317522450Plasma Calibrator Set Chromsystems Instruments + Chemicals GmbHJIX2019-07-26
04250317525055Plasma Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2019-07-26
04250317535139Plasma Calibration SetChromsystems Instruments + Chemicals GmbHJIX2019-07-26
04250317542755Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317542809Plasma Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317542854Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317543226Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317543233Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317543370Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22