FDA.report

ARCHITECT

Primary DI
00380740000400
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
1E50-20
Catalog number
01E5020
Device description
ICT Cleaning Fluid
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
JGSELECTRODE, ION SPECIFIC, SODIUM

Product Code Classifications

CodeDeviceSpecialtyClass
JGSElectrode, Ion Specific, SodiumClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380740000400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740000400003807400004003807400004000380740000400

GMDN Terms

TermDefinition
Wash/cleaning solution IVD, automated/semi-automated systemA concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.

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

Other Devices From This Company

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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

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00811403012541Sodium ElectrodeDiamond Diagnostics Inc.JGS2023-06-12
00811403015849Solution ValveDiamond Diagnostics Inc.JGS2023-06-06
00811403010165Sodium ElectrodeDiamond Diagnostics Inc.JGS2023-06-05
00811403015795Sodium ElectrodeDiamond Diagnostics Inc.JGS2023-06-05
00811403019984ProLyte Electrolyte AnalyzerDiamond Diagnostics Inc.JGS2023-06-05
00385480616218Stat ProfileNOVA BIOMEDICAL CORPORATIONJGS2022-12-07
00054749002597i-STATABBOTT POINT OF CARE INC.JGS2021-10-12
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00054749004386i-STATABBOTT POINT OF CARE INC.JGS2021-10-12
00054749004393i-STATABBOTT POINT OF CARE INC.JGS2021-10-12
04015630014286Sodium ElectrodeRoche Diagnostics GmbHJGS2021-07-30
04015630028702Roche 9180 Sodium electrodeRoche Diagnostics GmbHJGS2021-07-30
04987762129872Sodium ElectrodeJEOL LTD.JGS2020-09-15
00817302023213Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820CAROLINA LIQUID CHEMISTRIES CORPORATIONJGS2020-05-08
00817302023220Carolina Liquid Chemistries Corp. ISE Reference Solution DT88811CAROLINA LIQUID CHEMISTRIES CORPORATIONJGS2020-05-08
04580262010260Na ElectrodeTOKYO BOEKI MEDISYS INC.JGS2019-09-30
08426951070770GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2INSTRUMENTATION LABORATORY COMPANYJGS2019-06-28
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08426951070824GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, HctINSTRUMENTATION LABORATORY COMPANYJGS2019-06-28
08426951070831GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, HctINSTRUMENTATION LABORATORY COMPANYJGS2019-06-28
08426951070848GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, HctINSTRUMENTATION LABORATORY COMPANYJGS2019-06-28
00850229007324SelectaLyte (Sodium Electrode)AWARENESS TECHNOLOGY, INCORPORATEDJGS2019-06-26
00386100001636ISE Sodium electrode MEDICA CORPORATIONJGS2018-12-11
00386100001650ISE Disposable Reference Electrode MEDICA CORPORATIONJGS2018-12-11