ARCHITECT 05P0401

GUDID 00380740101220

TDM Multiconstituent Calibrator

ABBOTT LABORATORIES

Multiple-therapy therapeutic drug monitoring IVD, calibrator

Primary Device ID	00380740101220
NIH Device Record Key	b883f275-620c-4a64-bbdd-b6c4c3ecbf17
Commercial Distribution Status	In Commercial Distribution
Brand Name	ARCHITECT
Version Model Number	5P04-01
Catalog Number	05P0401
Company DUNS	079226220
Company Name	ABBOTT LABORATORIES
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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
Phone	+1(877)422-2688
Email	xx@xx.xx

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 0 and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740101220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K103403

FDA Product Code

JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2016-06-06

On-Brand Devices [ARCHITECT]

00380740169978	Architect c8000 CRP1 eAssay CD-ROM
00380740169848	Architect cSystem e-Assay CD-ROM SI-Units/Alternate Units
00380740169831	ARCHITECT cSystem eAssay CD-ROM Conventional Units/Alternate Units
00380740161323	ARCHITECT c Systems SI Units / Alternate Units MULTIGENT Assay Disk Version 7.00
00380740161316	ARCHITECT c Systems Conventional Units / Alternate Units MULTIGENT Assay Disk Version 7.00
00380740159429	ARCHITECT i1000SR System e-Assay CD-ROM
00380740159412	ARCHITECT i System e-Assay CD-ROM
00380740158507	CRP Vario
00380740158491	CRP Vario
00380740157067	ARCHITECT i1000sr System e-Assay CD ROM
00380740157050	ARCHITECT i System e-Assay CD-ROM
00380740156909	ARCHITECT cSystem Theophylline SI Units e-Assay CD-ROM v1.0
00380740156893	ARCHITECT cSystem Theophylline Conventional Units e-Assay CD-ROM v1.0
00380740156886	ARCHITECT cSystem Phenytoin SI Units e-Assay CD-ROM v1.0
00380740156879	ARCHITECT cSystem Phenytoin Conventional Units e-Assay CD-ROM v1.0
00380740153441	ARCHITECT i1000SR e-Assay CD-ROM
00380740153434	ARCHITECT i System e-Assay CD-ROM
00380740152147	ARCHITECT cSystem SI Units e-Assay CD ROM V15.0
00380740152130	ARCHITECT cSystem Conv Units e-Assay CD ROM V15.0
00380740150150	ARCHITECT i1000SR System e-Assay CD-ROM
00380740150143	ARCHITECT i System e-Assay CD-ROM
00380740146689	ARCHITECT UIBC-L SI Units e-Assay CD ROM
00380740146672	ARCHITECT UIBC-L Conv Units e-Assay CD ROM
00380740145194	ARCHITECT TBili Conv Units e-Assay CD-ROM
00380740145156	ARCHITECT TBili SI Units e- Assay CD-ROM
00380740139537	ARCHITECT i1000SR System e-Assay CDROM
00380740139520	ARCHITECT i System e-Assay CD-ROM
00380740138738	ARCHITECT ROMA
00380740138615	ARCHITECT i1000SR System e-Assay CD-ROM
00380740138608	ARCHITECT i System e-Assay CD-ROM
00380740137045	UIBC
00380740121075	Lactic Acid
00380740117061	ARCHITECT c16000 REFURBISHED PROCESSING MODULE
00380740116095	ARCHITECT c4000 PROCESSING MODULE INTEGRATED
00380740116057	ARCHITECT c4000 PROCESSING MODULE
00380740116019	ARCHITECT i1000SR INTEGRATED MODULE
00380740115289	ABBOTT ARCHITECT Reaction Vessels
00380740112196	Detergent B
00380740105464	ARCHITECT CA19-9XR Reagent Kit
00380740103163	ARCHITECT c8000 REFURBISHED PROCESSING MODULE
00380740103156	ARCHITECT i1000SR REFURBISHED PROCESSING MODULE
00380740102746	Hemoglobin A1c
00380740102739	Hemoglobin A1c Controls
00380740102722	Hemoglobin A1c Calibrators
00380740102715	Theophylline
00380740102708	Phenytoin
00380740102692	Phenobarbital
00380740102685	Carbamazepine
00380740102678	Lipid Multiconstituent Calibrator
00380740101220	TDM Multiconstituent Calibrator

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