FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740214487
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
04P5730
Catalog number
04P5730
Device description
ARCHITECT i1000SR System e-Assay CD-ROM-US Version 30.0
Published
2024-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740214487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740214487003807402144873807402144870380740214487

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

Contacts#

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

Regulatory Flags#

DUNS number
079226220
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00380740203061Alinity06P061506P06152025-09-24
00380740203078Alinity06P062506P06252025-09-24
00380740203092Alinity06P066106P06612025-09-24
00380740023386ARCHITECT03M740103M74012026-01-24
00380740225155ARCHITECT04J622804J62282026-01-03
00380740225162ARCHITECT08G982808G98282026-01-03
00380740224523ARCHITECT04P552804P55282026-01-01
00380740224530ARCHITECT04P573204P57322026-01-01
00380740213565Alinity09P680209P68022025-12-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06947145541781MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.JJE2026-05-15
00380740225186ARCHITECTABBOTT LABORATORIESJJE2026-05-14
00380740225193ARCHITECTABBOTT LABORATORIESJJE2026-05-14
07613336224397cobas ISE neo 1800 analytical unitRoche Diagnostics GmbHJJE2026-04-03
07613336200544cobas c 703 analytical unitRoche Diagnostics GmbHJJE2026-03-20
07613336220191cobas pro SBL c 703Roche Diagnostics GmbHJJE2026-03-20
00199874508153Spiral LaboratoriesSOCIETE ANONYME DE FABRICATION D'APPAREILS SCIENTIFIQUESJJE2026-02-10
00380740023386ARCHITECTABBOTT LABORATORIESJJE2026-01-24
06944904084459Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.JJE2026-01-23
00810053950098NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950388NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879023565NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879023831NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879023909NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879024685NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950159NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonHYCOR BIOMEDICAL LLCJJE2026-01-20
00810053950371NOVEOS Clam, Mercenaria mercenariaHYCOR BIOMEDICAL LLCJJE2026-01-20
00810053950401NOVEOS Walnut, Juglans spp. Juglans regia, Juglans nigraHYCOR BIOMEDICAL LLCJJE2026-01-20
00810053950500NOVEOS German Cockroach, Blatella germanicaHYCOR BIOMEDICAL LLCJJE2026-01-20
00816879023800NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonHYCOR BIOMEDICAL LLCJJE2026-01-20
00816879024463NOVEOS German Cockroach, Blatella germanicaHYCOR BIOMEDICAL LLCJJE2026-01-20
00816879024555NOVEOS Clam, Mercenaria mercenariaHYCOR BIOMEDICAL LLCJJE2026-01-20
00816879028010NOVEOS Walnut, Juglans spp. Juglans regia, Juglans nigraHYCOR BIOMEDICAL LLCJJE2026-01-20
00380740225155ARCHITECTABBOTT LABORATORIESJJE2026-01-03
00380740225162ARCHITECTABBOTT LABORATORIESJJE2026-01-03
00380740223748AlinityAbbott GmbHJJE2026-01-01
00380740224523ARCHITECTABBOTT LABORATORIESJJE2026-01-01
00380740224530ARCHITECTABBOTT LABORATORIESJJE2026-01-01