FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740007065
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
4D19-01
Catalog number
04D1901
Device description
ABBOTT ARCHITECT Replacement Caps
Published
2018-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
00380740007065PrimaryGS10
00380740151119Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740007065003807400070653807400070650380740007065
00380740151119003807401511193807401511190380740151119

GMDN Terms#

Term, Definition table
TermDefinition
Chemiluminescent immunoassay analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079226220
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740023386ARCHITECT03M740103M74012026-01-24
00380740225155ARCHITECT04J622804J62282026-01-03
00380740225162ARCHITECT08G982808G98282026-01-03
00380740224523ARCHITECT04P552804P55282026-01-01
00380740224530ARCHITECT04P573204P57322026-01-01
00380740213565Alinity09P680209P68022025-12-25
00380740213572Alinity09P690209P69022025-12-25
00380740213558Alinity06U810106U81012025-09-25
00380740202958Alinity06P060706P06072025-09-24
00380740203061Alinity06P061506P06152025-09-24
00380740203078Alinity06P062506P06252025-09-24
00380740203092Alinity06P066106P06612025-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00380740225155ARCHITECTABBOTT LABORATORIESJJE2026-01-03
00380740225162ARCHITECTABBOTT LABORATORIESJJE2026-01-03
00380740223748AlinityAbbott GmbHJJE2026-01-01
00380740224523ARCHITECTABBOTT LABORATORIESJJE2026-01-01
00380740224530ARCHITECTABBOTT LABORATORIESJJE2026-01-01
00380740186241AlinityAbbott GmbHJJE2025-12-19
00380740186258AlinityAbbott GmbHJJE2025-12-19
00380740213398AlinityAbbott GmbHJJE2025-12-19
00380740213404AlinityAbbott GmbHJJE2025-12-19
00380740213411AlinityAbbott GmbHJJE2025-12-19
00380740213428AlinityAbbott GmbHJJE2025-12-19
00380740199074AlinityAbbott GmbHJJE2025-11-27
00380740215224AlinityAbbott GmbHJJE2025-09-29
04260678680010GEMINISTRATEC SEJJE2025-09-05
00380740220556ARCHITECTABBOTT LABORATORIESJJE2025-08-22
00380740220563ARCHITECTABBOTT LABORATORIESJJE2025-08-22
00380740220495ARCHITECTABBOTT LABORATORIESJJE2025-08-02
00380740220501ARCHITECTABBOTT LABORATORIESJJE2025-08-02
05999883586419P780 Clinical Chemistry Analyzer with ISE moduleDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-07-10
05999883586426P780 Clinical Chemistry AnalyzerDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-07-10
05999883586907Atellica DT Cuvettes (280pcs)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-06-13
10758750035656VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JJE2025-05-21
03701700860358Viva-ProEVitalScientific B.V.JJE2025-04-30
15999883586744Atellica DT 250 Analyzer Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-04-30
00380740186425AlinityAbbott GmbHJJE2025-04-15
00380740190644ARCHITECTABBOTT LABORATORIESJJE2025-04-15