ARCHITECT 06L2310

GUDID 00380740011147

ARCHITECT CORE-M Controls

Abbott GmbH & Co. KG

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Primary Device ID00380740011147
NIH Device Record Keyfc81249c-e3e0-4127-8cf8-cf3518036722
Commercial Distribution StatusIn Commercial Distribution
Brand NameARCHITECT
Version Model Number6L23-10
Catalog Number06L2310
Company DUNS315786293
Company NameAbbott GmbH & Co. KG
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
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx
Phone+1(877)422-2688
Emailxxx@xxx.xxx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100380740011147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOMTest, hepatitis b (b core, be antigen, be antibody, b core igm)

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 Date2014-11-18

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Trademark Results [ARCHITECT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
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
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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
ARCHITECT
ARCHITECT
85311925 4053176 Live/Registered
BOSCOV'S DEPARTMENT STORE, LLC
2011-05-04

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