ARCHITECT 04P5725

GUDID 00380740192761

ARCHITECT i1000SR System e-Assay CD-ROM-US Version 25.0

ABBOTT LABORATORIES

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD
Primary Device ID00380740192761
NIH Device Record Key9a6bc087-d2f2-4c30-9067-912b6462c76f
Commercial Distribution StatusIn Commercial Distribution
Brand NameARCHITECT
Version Model Number04P5725
Catalog Number04P5725
Company DUNS079226220
Company NameABBOTT LABORATORIES
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100380740192761 [Primary]
GS100380740192761 [Primary]
GS100380740192761 [Primary]
GS100380740192761 [Primary]
GS100380740192761 [Primary]
GS100380740192761 [Primary]
GS100380740192761 [Primary]
GS100380740192761 [Primary]

FDA Product Code

JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

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00380740169848Architect cSystem e-Assay CD-ROM SI-Units/Alternate Units
00380740169831ARCHITECT cSystem eAssay CD-ROM Conventional Units/Alternate Units
00380740161323ARCHITECT c Systems SI Units / Alternate Units MULTIGENT Assay Disk Version 7.00
00380740161316ARCHITECT c Systems Conventional Units / Alternate Units MULTIGENT Assay Disk Version 7.00
00380740159429ARCHITECT i1000SR System e-Assay CD-ROM
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00380740157067ARCHITECT i1000sr System e-Assay CD ROM
00380740157050ARCHITECT i System e-Assay CD-ROM
00380740156909ARCHITECT cSystem Theophylline SI Units e-Assay CD-ROM v1.0
00380740156893ARCHITECT cSystem Theophylline Conventional Units e-Assay CD-ROM v1.0
00380740156886ARCHITECT cSystem Phenytoin SI Units e-Assay CD-ROM v1.0
00380740156879ARCHITECT cSystem Phenytoin Conventional Units e-Assay CD-ROM v1.0
00380740153441ARCHITECT i1000SR e-Assay CD-ROM
00380740153434ARCHITECT i System e-Assay CD-ROM
00380740152147ARCHITECT cSystem SI Units e-Assay CD ROM V15.0
00380740152130ARCHITECT cSystem Conv Units e-Assay CD ROM V15.0
00380740150150ARCHITECT i1000SR System e-Assay CD-ROM
00380740150143ARCHITECT i System e-Assay CD-ROM
00380740146689ARCHITECT UIBC-L SI Units e-Assay CD ROM
00380740146672ARCHITECT UIBC-L Conv Units e-Assay CD ROM
00380740145194ARCHITECT TBili Conv Units e-Assay CD-ROM
00380740145156ARCHITECT TBili SI Units e- Assay CD-ROM
00380740139537ARCHITECT i1000SR System e-Assay CDROM
00380740139520ARCHITECT i System e-Assay CD-ROM
00380740138738ARCHITECT ROMA
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00380740138608ARCHITECT i System e-Assay CD-ROM
00380740137045UIBC
00380740121075Lactic Acid
00380740117061ARCHITECT c16000 REFURBISHED PROCESSING MODULE
00380740116095ARCHITECT c4000 PROCESSING MODULE INTEGRATED
00380740116057ARCHITECT c4000 PROCESSING MODULE
00380740116019ARCHITECT i1000SR INTEGRATED MODULE
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00380740112196Detergent B
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00380740102746Hemoglobin A1c
00380740102739Hemoglobin A1c Controls
00380740102722Hemoglobin A1c Calibrators
00380740102715Theophylline
00380740102708Phenytoin
00380740102692Phenobarbital
00380740102685Carbamazepine
00380740102678Lipid Multiconstituent Calibrator
00380740101220TDM Multiconstituent Calibrator

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