FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740155490
Brand
ARCHITECT
Company
ABBOTT IRELAND
Model
04U4530
Catalog number
04U4530
Device description
Albumin BCP2 2200 Tests
Published
2024-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CJWBROMCRESOL PURPLE DYE-BINDING, ALBUMIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJWBromcresol Purple Dye-Binding, AlbuminClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740155490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740155490003807401554903807401554900380740155490

GMDN Terms#

Term, Definition table
TermDefinition
Albumin IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using a spectrophotometry method. It is typically used for the detection of small amounts of albumin in urine as an indicator of a kidney disease known as moderately increased albuminuria or microalbuminuria.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
989964119
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740180713Alinity04U002004U00202025-10-24
00380740180720ARCHITECT04T042004T04202025-10-24
00380740204020ARCHITECT04T040104T04012025-10-24
00380740204037Alinity04U000104U00012025-10-24
00380740130572Alinity07P944007P94402020-07-03
00380740014346ARCHITECT7K64-5007K64502016-09-09
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15
00380740155889ARCHITECT04T343004T34302024-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654003Atellica CH AlbPSiemens Healthcare Diagnostics Inc.CJW2026-03-18
00380740155285AlinityABBOTT IRELANDCJW2024-08-15
00380740155292AlinityABBOTT IRELANDCJW2024-08-15
00380740155483ARCHITECTABBOTT IRELANDCJW2024-08-15
08058056681973Albumin BCP (6x20 mL)SENTINEL CH. SPACJW2020-02-24
08058056681980Albumin BCP (6x50 mL)SENTINEL CH. SPACJW2020-02-24
00380740121723AlinityAbbott GmbHCJW2018-07-11
00630414595825Atellica CH AlbPSiemens Healthcare Diagnostics Inc.CJW2017-12-22
00842768005343Dimension® Flex® reagent cartridge ALBSiemens Healthcare Diagnostics Inc.CJW2016-09-24
00842768015021Dimension Vista® Flex® reagent cartridge ALBSiemens Healthcare Diagnostics Inc.CJW2016-09-24
00630414947402ADVIA® Chemistry Albumin BCP ReagentsSiemens Healthcare Diagnostics Inc.CJW2016-09-24
00630414947419ADVIA® Chemistry Albumin BCP ReagentsSiemens Healthcare Diagnostics Inc.CJW2016-09-24
EABA40000031Piccolo Liver Panel PlusABAXIS, INC.CJW2016-09-23
EABA40000261Piccolo Hepatic Function PanelABAXIS, INC.CJW2016-09-23
EABA40000271Piccolo Renal Function PanelABAXIS, INC.CJW2016-09-23
EABA40000281Piccolo Comprehensive Metabolic PanelABAXIS, INC.CJW2016-09-23
EABA40000291Piccolo General Chemistry 13ABAXIS, INC.CJW2016-09-23
EABA40000351Piccolo BioChemistry Panel PlusABAXIS, INC.CJW2016-09-23
EABA40000371Piccolo MetLac 12 PanelABAXIS, INC.CJW2016-09-23
EABA40000411Piccolo AmLyte 13ABAXIS, INC.CJW2016-09-23
04015630928064Albumin BCPRoche Diagnostics GmbHCJW2016-09-20
04015630990634AlbuminBCP AlbuminBCPRoche Diagnostics GmbHCJW2016-09-20
00851445007006GENCHEM™ Albumin ReagentGENCHEM INCCJW2016-09-19
05055273200034ALBRANDOX LABORATORIES LIMITEDCJW2016-09-16
00817302020229CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214CAROLINA LIQUID CHEMISTRIES CORPORATIONCJW2016-09-01
00817302020946CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214CAROLINA LIQUID CHEMISTRIES CORPORATIONCJW2016-09-01
15099590233341SynchronBeckman Coulter, Inc.CJW2016-08-24
15099590625719SynchronBeckman Coulter, Inc.CJW2016-08-24
00380740012816ARCHITECTABBOTT LABORATORIESCJW2016-06-06