ARCHITECT 06K5002

GUDID 00380740030100

Quantia IgE Calibrators

ABBOTT LABORATORIES

Total immunoglobulin E (IgE total) IVD, calibrator
Primary Device ID00380740030100
NIH Device Record Keyddd292ca-6082-4398-ba03-61aa48fed04c
Commercial Distribution StatusIn Commercial Distribution
Brand NameARCHITECT
Version Model Number6K50-02
Catalog Number06K5002
Company DUNS079226220
Company NameABBOTT LABORATORIES
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
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
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Handling Environment TemperatureBetween 0 and 29 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100380740030100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJSCONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-09

On-Brand Devices [ARCHITECT]

00380740169978Architect c8000 CRP1 eAssay CD-ROM
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
00380740159412ARCHITECT i System e-Assay CD-ROM
00380740158507CRP Vario
00380740158491CRP Vario
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
00380740138615ARCHITECT i1000SR System e-Assay CD-ROM
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
00380740115289ABBOTT ARCHITECT Reaction Vessels
00380740112196Detergent B
00380740105464ARCHITECT CA19-9XR Reagent Kit
00380740103163ARCHITECT c8000 REFURBISHED PROCESSING MODULE
00380740103156ARCHITECT i1000SR REFURBISHED PROCESSING MODULE
00380740102746Hemoglobin A1c
00380740102739Hemoglobin A1c Controls
00380740102722Hemoglobin A1c Calibrators
00380740102715Theophylline
00380740102708Phenytoin
00380740102692Phenobarbital
00380740102685Carbamazepine
00380740102678Lipid Multiconstituent Calibrator
00380740101220TDM Multiconstituent Calibrator

Trademark Results [ARCHITECT]

Mark Image

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

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