FDA.report

ARCHITECT

Primary DI
00380740161644
Brand
ARCHITECT
Company
Abbott GmbH & Co. KG
Model
7D53-24
Catalog number
07D5324
Device description
Albumin BCG
Published
2019-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CIXBROMCRESOL GREEN DYE-BINDING, ALBUMIN

Product Code Classifications

CodeDeviceSpecialtyClass
CIXBromcresol Green Dye-Binding, AlbuminClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380740161644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740161644003807401616443807401616440380740161644

GMDN Terms

TermDefinition
Albumin IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of albumin in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags

DUNS number
315786293
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00380740170264Alinity09P521A09P521A2020-05-11
00380740170271Alinity09P523A09P523A2020-05-11
00380740121754Alinity08P072108P07212020-05-06
00380740121778Alinity08P073108P07312020-05-06
00380740136574Alinity08P071208P07122020-05-06
00380740146252Alinity08P070208P07022020-05-06
00380740151744Alinity09P411A09P411A2020-05-01
00380740154387Alinity08P073A08P073A2020-05-01
00380740163556ARCHITECT5P56-0205P56022020-05-02
00380740161798ARCHITECT7D79-2207D79222020-04-18
00380740161804ARCHITECT7D79-3207D79322020-04-18
00380740190361ARCHITECT08K280408K28042020-04-15
00380740190378ARCHITECT08K281308K28132020-04-15
00380740154325Alinity09P140309P14032018-07-30
00380740174965ARCHITECT6L45-2206L45222020-04-12
00380740174972ARCHITECT6L45-4206L45422020-04-12
00380740170318Alinity09P551A09P551A2020-03-27
00380740170325Alinity09P553A09P553A2020-03-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00380740155346AlinityABBOTT IRELANDCIX2024-08-15
00380740155353AlinityABBOTT IRELANDCIX2024-08-15
00380740155872ARCHITECTABBOTT IRELANDCIX2024-08-15
00380740155889ARCHITECTABBOTT IRELANDCIX2024-08-15
00850053916007IDG/SanzayIDG/SANZAY CorporationCIX2023-12-18
10673486001013Albumin Reagent SetTECO DIAGNOSTICSCIX2023-07-07
10673486001020Albumin -BCG method TC-MatrixTECO DIAGNOSTICSCIX2023-07-07
00811727016003Pointe Albumin Reagent POINTE SCIENTIFIC, INC.CIX2021-01-30
00811727015693Pointe Albumin on BS480 AnalyzerPOINTE SCIENTIFIC, INC.CIX2020-05-28
10758750031771VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CIX2020-05-16
03610230006825Yumizen C1200 AlbuminHORIBA ABX SASCIX2020-05-06
07613336120941Albumin Gen.2Roche Diagnostics GmbHCIX2020-03-05
07613336120958Albumin Gen.2Roche Diagnostics GmbHCIX2020-03-05
00386100002145ALB Reagent KitMEDICA CORPORATIONCIX2019-02-14
00380740121716AlinityAbbott GmbH & Co. KGCIX2018-07-11
00852169008010ClearChem Diagnostics Inc. AlbuminCLEARCHEM DIAGNOSTICS INC.CIX2018-04-30
00817274022696JAS DiagnosticsDREW SCIENTIFIC, INC.CIX2018-04-26
00630414596501Atellica CH AlbSiemens Healthcare Diagnostics Inc.CIX2017-12-22
05060500091682Synermed®INFRARED LABORATORY SYSTEMS LLCCIX2017-02-28
00817302022957CAROLINA LIQUID CHEMISTRIES CORP.® ALB REAGENT PRODUCT NO. DT224CAROLINA LIQUID CHEMISTRIES CORPORATIONCIX2016-10-17
00812137011848Albumin ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIX2016-10-12
00081213701184Albumin ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIX2016-10-12
00817274022313JAS DiagnosticsDREW SCIENTIFIC, INC.CIX2016-10-11
00817439020093Albumin / BS480Medtest Dx, Inc.CIX2016-09-27
00817439020109AlbuminMedtest Dx, Inc.CIX2016-09-27
00817439020116Albumin / BS200Medtest Dx, Inc.CIX2016-09-27
15099590010010AUBeckman Coulter, Inc.CIX2016-09-24
15099590020002AUBeckman Coulter, Inc.CIX2016-09-24
15099590060008AUBeckman Coulter, Inc.CIX2016-09-24
00857969006136ACEALFA WASSERMANN, INC.CIX2016-09-24