FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740003821
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
2P32-50
Catalog number
02P3250
Device description
ICT Sample Diluent
Published
2016-06-06
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
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
JGSELECTRODE, ION SPECIFIC, SODIUM
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740003821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740003821003807400038213807400038210380740003821

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, manualA buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.

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
079226220
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03
00380740202835Alinity06P012506P01252025-10-03
00380740202859Alinity06P016106P01612025-10-03
00380740202996Alinity06P080706P08072025-09-17
00380740203023Alinity06P081506P08152025-09-17
00380740203030Alinity06P082506P08252025-09-17
00380740203054Alinity06P086106P08612025-09-17
00380740196257GLP systems Track04Z965104Z96512023-08-30
00380740225186ARCHITECT04P553004P55302026-05-14
00380740225193ARCHITECT04P573304P57332026-05-14
00380740003197ARCHITECT2K41-1002K41102016-06-06
00380740138851Alinity09P680109P68012023-11-16
00380740138868Alinity09P690109P69012023-11-16
00380740203191Alinity06P023006P02302025-09-24
00380740203214Alinity06P020606P02062025-09-24
00380740203238Alinity06P022006P02202025-09-24
00380740203252Alinity06P026106P02612025-09-24
00380740203276Alinity06P035806P03582025-09-24
00380740202958Alinity06P060706P06072025-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740225186ARCHITECTABBOTT LABORATORIESJJE2026-05-14
00380740225193ARCHITECTABBOTT LABORATORIESJJE2026-05-14
07613336224397cobas ISE neo 1800 analytical unitRoche Diagnostics GmbHJJE2026-04-03
00380740223700ARCHITECTABBOTT LABORATORIESJJE2025-11-08
00380740223717ARCHITECTABBOTT LABORATORIESJJE2025-11-08
00380740186524AlinityAbbott GmbHJJE2025-10-24
00380740023089ARCHITECTABBOTT LABORATORIESJJE2025-10-17
00380740194765AlinityAbbott GmbHJJE2025-10-14
00380740215712AlinityABBOTT LABORATORIESCGZ2025-10-08
00380740215712AlinityABBOTT LABORATORIESCEM2025-10-08
00380740215712AlinityABBOTT LABORATORIESJJE2025-10-08
00380740215712AlinityABBOTT LABORATORIESJGS2025-10-08
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJJE2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJJE2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJJE2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJJE2025-05-28
00380740157173AlinityAbbott Ireland DiagnosticsJJE2024-07-18
00380740214487ARCHITECTABBOTT LABORATORIESJJE2024-07-11
00380740196257GLP systems TrackABBOTT LABORATORIESJJE2023-08-30
10758750031658VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CGZ2023-04-28
00380740195205AlinityAbbott GmbHJJE2023-01-06
00380740204082ARCHITECTABBOTT LABORATORIESJJE2023-01-06
00380740195458AlinityAbbott GmbHJJE2022-09-16
00380740202231ARCHITECTABBOTT LABORATORIESJJE2022-09-16
00380740202248ARCHITECTABBOTT LABORATORIESJJE2022-09-16
08033622964544EnvoyBIOTECNICA INSTRUMENTS SPAJJE2020-09-18
10054749005519i-STATABBOTT POINT OF CARE INC.CEM2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CGZ2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.JGS2020-05-01
00380740156855ARCHITECTABBOTT LABORATORIESCEM2019-10-31