ARCHITECT 07P3241

GUDID 00380740129040

Total Bilirubin

Abbott GmbH & Co. KG

Total bilirubin IVD, kit, spectrophotometry

Primary Device ID	00380740129040
NIH Device Record Key	203161ca-4881-4035-8cfe-74e83dbe9480
Commercial Distribution Status	In Commercial Distribution
Brand Name	ARCHITECT
Version Model Number	7P32-41
Catalog Number	07P3241
Company DUNS	315786293
Company Name	Abbott GmbH & Co. KG
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

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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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 0 and 29 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740129040 [Primary]

FDA Product Code

CIG	DIAZO COLORIMETRY, BILIRUBIN

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	2016-12-31

On-Brand Devices [ARCHITECT]

00380740156527	ARCHITECT Homocysteine Reagent Kit
00380740150907	Alkaline Phosphatase
00380740150891	Alkaline Phosphatase
00380740145408	ARCHITECT CA19-9XR Controls
00380740145392	ARCHITECT CA19-9XR Calibrators
00380740145385	ARCHITECT CA 125 II Reagent Kit
00380740145378	ARCHITECT CA 125 II Reagent Kit
00380740145361	ARCHITECT CA 125 II Reagent Kit
00380740145354	ARCHITECT CA 125 II Controls
00380740145347	ARCHITECT CA 125 II Calibrators
00380740145330	ARCHITECT CA 15-3 Reagent Kit
00380740145323	ARCHITECT CA 15-3 Reagent Kit
00380740145316	ARCHITECT CA 15-3 Reagent Kit
00380740145309	ARCHITECT CA 15-3 Controls
00380740145293	ARCHITECT CA 15-3 Calibrators
00380740145286	ARCHITECT BNP Reagent Kit
00380740145279	ARCHITECT BNP Reagent Kit
00380740145262	ARCHITECT BNP Controls
00380740145255	ARCHITECT BNP Calibrators
00380740139049	ARCHITECT B.R.A.H.M.S PCT Reagent Kit
00380740139032	ARCHITECT B.R.A.H.M.S PCT Reagent Kit
00380740138912	ARCHITECT B.R.A.H.M.S PCT Controls
00380740138905	ARCHITECT B.R.A.H.M.S PCT Calibrators
00380740137304	ARCHITECT CA19-9XR Reagent Kit
00380740129040	Total Bilirubin
00380740129033	Total Bilirubin
00380740119416	Microalbumin
00380740119409	Microalbumin Controls
00380740119393	Microalbumin Calibrators
00380740117122	ARCHITECT Syphilis TP Reagent Kit
00380740117115	ARCHITECT Syphilis TP Reagent Kit
00380740112776	ARCHITECT Intact PTH Controls
00380740112769	ARCHITECT Intact PTH Calibrators
00380740105327	ARCHITECT iVancomycin Reagent Kit
00380740103545	ARCHITECT Syphilis TP Controls
00380740103538	ARCHITECT Syphilis TP Calibrator
00380740099473	ARCHITECT 2nd Generation Testosterone Reagent Kit
00380740096618	ARCHITECT Galectin-3 Reagent Kit
00380740096144	ARCHITECT Galectin-3 Controls
00380740096137	ARCHITECT Galectin-3 Calibrators
00380740082147	ARCHITECT 25-OH Vitamin D Reagent Kit
00380740082130	ARCHITECT 25-OH Vitamin D Reagent Kit
00380740082123	ARCHITECT 25-OH Vitamin D Controls
00380740082116	ARCHITECT 25-OH Vitamin D Calibrators
00380740081935	ARCHITECT iCarbamazepine Calibrator A Multi-Pack
00380740081072	ARCHITECT iCarbamazepine Reagent Kit
00380740048471	ARCHITECT Intact PTH Reagent Kit
00380740048433	ARCHITECT HE4 Reagent Kit
00380740017453	ARCHITECT DHEA-S Reagent Kit
00380740017439	ARCHITECT DHEA-S Controls

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