FDA.reportPublic FDA data

ACE

Primary DI
00857969006136
Brand
ACE
Company
ALFA WASSERMANN, INC.
Model
SA2001
Catalog number
SA2001
Device description
Albumin Reagent
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CIXBromcresol Green Dye-Binding, Albumin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIXBromcresol Green Dye-Binding, AlbuminClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857969006136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857969006136008579690061368579690061360857969006136

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius26 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
973-852-0158HKatz@AlfaWassermannUS.com

Regulatory Flags#

DUNS number
781990924
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857969006068ACERX1012RX10122016-09-24
00857969006112ACESA1012SA10122016-09-24
00857969006433Alfa WassermannC2-87C2-872017-10-10
00857969006693ACE Alera®402900-1402900-12021-01-07
00857969006709ACE Axcel®404200-1404200-12021-01-07
00857969006181Alfa WassermannS1-33S1-332016-09-24
00857969006198Alfa WassermannS2-85S2-852016-09-24
00857969006396Alfa WassermannC1-42017-07-25
00857969006402Alfa WassermannC1-5C1-52017-07-25
00857969006662ACESA1052SA10522020-07-01
00857969006679ACESA1053SA10532020-07-01
00857969006686ACERX1053RX10532020-07-01
00857969006624ACESA1020SA10202020-04-09
00857969006631ACESA1021SA10212020-04-09
00857969006648ACESA1027SA10272020-04-09
00857969006655ACESA1028SA10282020-04-09
00857969006600Alfa WassermannS2-87S2-872020-04-03
00857969006617ACESA1050SA10502020-04-03
00857969006020ACEACI-32ACI-322017-10-10
00857969006419ACEC2-85C2-852017-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654140Atellica CH AlbSiemens Healthcare Diagnostics Inc.CIX2026-03-18
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
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 HORIBA INSTRUMENTS INCORPORATEDCIX2021-01-30
00811727015693Pointe Albumin on BS480 AnalyzerHORIBA INSTRUMENTS INCORPORATEDCIX2020-05-28
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
00380740161644ARCHITECTAbbott GmbHCIX2019-11-15
00386100002145ALB Reagent KitMEDICA CORPORATIONCIX2019-02-14
00380740121716AlinityAbbott GmbHCIX2018-07-11
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