FDA.report

ARCHITECT

Primary DI
00380740000370
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
1E47-02
Catalog number
01E4702
Device description
ICT Urine Calibrator
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CEMELECTRODE, ION SPECIFIC, POTASSIUM

Product Code Classifications

CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380740000370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740000370003807400003703807400003700380740000370

GMDN Terms

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

TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags

DUNS number
079226220
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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00380740213565Alinity09P680209P68022025-12-25
00380740213572Alinity09P690209P69022025-12-25
00380740213558Alinity06U810106U81012025-09-25
00380740202958Alinity06P060706P06072025-09-24
00380740203061Alinity06P061506P06152025-09-24
00380740203078Alinity06P062506P06252025-09-24
00380740203092Alinity06P066106P06612025-09-24
00380740203191Alinity06P023006P02302025-09-24
00380740203214Alinity06P020606P02062025-09-24
00380740203238Alinity06P022006P02202025-09-24
00380740203252Alinity06P026106P02612025-09-24
00380740203276Alinity06P035806P03582025-09-24
00380740202996Alinity06P080706P08072025-09-17
00380740203023Alinity06P081506P08152025-09-17
00380740203030Alinity06P082506P08252025-09-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06936415904661MR Na/K Check SolutionShenzhen Mindray Bio-Medical Electronics Co., Ltd.CEM2026-01-23
03701700860419SelectraVitalScientific B.V.CEM2025-05-06
07613336227770Potassium electrodeRoche Diagnostics GmbHCEM2025-03-05
07613336227794Reference electrodeRoche Diagnostics GmbHCEM2025-03-05
07640172344002FlexLab XInpeco SACEM2024-07-30
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSCEM2024-07-01
03661540304156Potassium ElectrodeELITECHGROUP INC.CEM2023-10-01
00811403012558Potassium ElectrodeDiamond Diagnostics Inc.CEM2023-06-12
00811403015931Sample DetectorDiamond Diagnostics Inc.CEM2023-06-06
00811403015948Membrane AssemblyDiamond Diagnostics Inc.CEM2023-06-06
00811403010127Potassium ElectrodeDiamond Diagnostics Inc.CEM2023-06-05
00811403015788Potassium ElectrodeDiamond Diagnostics Inc.CEM2023-06-05
00811403019892SmartLyte Electrolyte AnalyzerDiamond Diagnostics Inc.CEM2023-06-05
04015630028689Roche 9180 Potassium electrodeRoche Diagnostics GmbHCEM2021-07-30
04987762129865Potassium ElectrodeJEOL LTD.CEM2020-09-15
04580262010277K ElectrodeTOKYO BOEKI MEDISYS INC.CEM2019-09-30
00894472000244OPTI CCA E CassetteOPTI MEDICAL SYSTEMS, INC.CEM2019-08-07
00850229007331SelectaLyte (Potassium Electrode)AWARENESS TECHNOLOGY, INCORPORATEDCEM2019-06-26
00386100001643ISE Potassium Electrode MEDICA CORPORATIONCEM2018-12-11
00386100002466Potassium ElectrodeMEDICA CORPORATIONCEM2018-12-05
00386100002398Daily Cleaning Solution Kit MEDICA CORPORATIONCEM2018-12-04
00386100002862Na/K AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002985Reference ElectrodeMEDICA CORPORATIONCEM2018-12-04
00386100003029Na/K Solution PackMEDICA CORPORATIONCEM2018-12-04
00386100003081Na/K Solution Pack MEDICA CORPORATIONCEM2018-12-04
00386100003173Membrane Assembly MEDICA CORPORATIONCEM2018-12-04
00386100003180Capillary Adapter Cleaning Kit MEDICA CORPORATIONCEM2018-12-04
00386100003197Capillary tubesMEDICA CORPORATIONCEM2018-12-04
00386100003203Wash Solution MEDICA CORPORATIONCEM2018-12-04
00386100003210Internal Filling SolutionMEDICA CORPORATIONCEM2018-12-04