ARCHITECT 07D8250

GUDID 00380740013066

ARCHITECT Multi -Assay Manual Diluent

Abbott Ireland Diagnostics

Buffered sample diluent IVD, manual

Primary Device ID	00380740013066
NIH Device Record Key	00a0305a-bf01-48fa-a2ac-43e785893f71
Commercial Distribution Status	In Commercial Distribution
Brand Name	ARCHITECT
Version Model Number	7D82-50
Catalog Number	07D8250
Company DUNS	985307301
Company Name	Abbott Ireland Diagnostics
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Operating and Storage Conditions

Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740013066 [Primary]

FDA Product Code

JJE	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-08-31
Device Publish Date	2018-07-31

On-Brand Devices [ARCHITECT]

00380740115388	ARCHITECT AUSAB Specimen Diluent
00380740115371	ARCHITECT AUSAB Reagent
00380740115364	ARCHITECT AUSAB Reagent
00380740112424	ARCHITECT CEA Reagent kit
00380740112400	ARCHITECT AFP Reagent Kit
00380740105433	ARCHITECT AUSAB Reagent
00380740105426	ARCHITECT AUSAB Reagent
00380740105419	ARCHITECT AUSAB Controls
00380740105402	ARCHITECT AUSAB Calibrators
00380740081317	ARCHITECT AFP Reagent Kit
00380740081294	ARCHITECT AFP Controls
00380740081287	ARCHITECT AFP Calibrators
00380740014582	ARCHITECT CEA Reagent kit
00380740014575	ARCHTECT CEA Reagent kit
00380740014551	ARCHITECT CEA Controls
00380740014544	ARCHITECT CEA Calibrators
00380740013066	ARCHITECT Multi -Assay Manual Diluent
00380740009786	ARCHITECT PRE TRIGGER SOLUTION
00380740009625	ARCHITECT TRIGGER SOLUTION
00380740009618	ARCHITECT CONCENTRATED WASH BUFFER (10L)
00380740009601	ARCHITECT CONCENTRATED WASH BUFFER
00380740009021	ARCHITECT Free PSA Reagent Kit
00380740009014	ARCHITECT Free PSA Controls
00380740009007	ARCHITECT Free PSA Calibrators
00380740008994	ARCHITECT Total PSA Reagent Kit
00380740008987	ARCHITECT Total PSA Reagent Kit
00380740008970	ARCHITECT Total PSA Controls
00380740008963	ARCHITECT Total PSA Calibrators
00380740007805	ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent
00380740007799	ARCHITECT HBsAg Qualitative Confirmatory Reagent Kit
00380740007782	ARCHITECT HBsAg Qualitative Reagent Kit
00380740007775	ARCHITECT HBsAg Qualitative Reagent Kit
00380740007768	ARCHITECT HBsAg Qualitative Controls
00380740007751	ARCHITECT HBsAg Qualitative Calibrators
00380740001520	ARCHITECT AUSAB Reagent Kit
00380740001513	ARCHITECT AUSAB Reagent Kit
00380740001506	ARCHITECT AUSAB Controls
00380740001490	ARCHITECT AUSAB Calibrators
00380740001193	ARCHITECT Probe Conditioning Solution
00380740193782	AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test
00380740193768	AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test
00380740193744	AdviseDx SARS-CoV-2 IgG II Control Kit
00380740193720	AdviseDx SARS-CoV-2 IgG II Calibrator Kit
00380740208486	ARCHITECT HBsAg Next Qualitative Calibrators
00380740208479	ARCHITECT HBsAg Next Confirmatory Manual Diluent
00380740208462	ARCHITECT HBsAg Next Qualitative Controls
00380740163389	ARCHITECT HBsAg Next Qualitative Reagent Kit (2000T)
00380740158187	ARCHITECT HBsAg Next Confirmatory Reagent Kit (100T)
00380740157012	ARCHITECT HBsAg Next Qualitative Reagent Kit (500T)
00380740156992	ARCHITECT HBsAg Next Qualitative Reagent Kit (100T)

Trademark Results [ARCHITECT]

Mark Image Registration \| Serial	Company Trademark Application Date
ARCHITECT 98626848 not registered Live/Pending	Architect Financial Technologies Inc. 2024-07-01
ARCHITECT 98211082 not registered Live/Pending	Radians, Inc. 2023-10-05
ARCHITECT 98120965 not registered Live/Pending	Activated Agency Group LLC 2023-08-07
ARCHITECT 97672276 not registered Live/Pending	Penelope Bourbon LLC 2022-11-10
ARCHITECT 97375247 not registered Live/Pending	Broadbent Selections, Inc. 2022-04-21
ARCHITECT 88875023 not registered Live/Pending	PREMIUM OUTDOOR PRODUCTS, LTD. 2020-04-16
ARCHITECT 88797756 not registered Live/Pending	DQC International Corp. 2020-02-14
ARCHITECT 88628662 not registered Live/Pending	Bowden Tactical LLC 2019-09-24
ARCHITECT 87650723 not registered Dead/Abandoned	AFM, LLC 2017-10-18
ARCHITECT 85971577 4527055 Live/Registered	Harbor MedTech, Inc. 2013-06-27
ARCHITECT 85733527 not registered Dead/Abandoned	Bristol-Myers Squibb Company 2012-09-20
ARCHITECT 85644736 4419447 Live/Registered	ALTISOURCE SOLUTIONS S.Ã R.L. 2012-06-06