FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740012830
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
7D55-31
Catalog number
07D5531
Device description
Alkaline Phosphatase
Published
2016-09-09
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
CJENITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJENitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740012830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740012830003807400128303807400128300380740012830

GMDN Terms#

Term, Definition table
TermDefinition
Total alkaline phosphatase (ALP) 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 total alkaline phosphatase (ALP) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature029 Degrees Celsius
Special Storage Condition, Specify00R2 reagent is light sensitive. Always store reagents protected from light.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079226220
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
00380740138783Alinity09P710109P71012023-11-16
00380740136963Alinity07P810407P81042023-11-16
00380740136994Alinity07P830107P83012023-11-16
00380740137007Alinity07P800407P80042023-11-16
00380740137021Alinity07P790407P79042023-11-16
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850053916014IDG/SanzayIDG/SANZAY CorporationCJE2024-01-03
10673486001044Alkaline Phosphatase (ALP) Kinetic Method TC Matrix-240/480TECO DIAGNOSTICSCJE2023-07-14
10673486001051Alkaline Phosphatase (Kinetic Procedure)TECO DIAGNOSTICSCJE2023-07-14
10673486001068Alkaline Phosphatase (Kinetic Procedure)TECO DIAGNOSTICSCJE2023-07-14
10673486002362Alkaline Phosphatase Liquid Reagent (Kinetic Procedure)TECO DIAGNOSTICSCJE2023-07-14
00811727016010Pointe Alkaline Phosphatase ReagentHORIBA INSTRUMENTS INCORPORATEDCJE2021-01-30
00811727015709Pointe Alkaline Phosphatase on the BS480HORIBA INSTRUMENTS INCORPORATEDCJE2020-05-28
03610230006832Yumizen C1200 ALPHORIBA ABX SASCJE2020-05-06
07613336120972Alkaline phosphatase acc. to IFCC Gen.2Roche Diagnostics GmbHCJE2020-03-05
10758750031801VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CJE2019-11-13
05055273208207ALKALINE PHOSPHATASE (ALP)RANDOX LABORATORIES LIMITEDCJE2019-06-03
00386100002107ALP Reagent Kit MEDICA CORPORATIONCJE2019-02-14
00628063401192Alkaline PhosphataseSekisui Diagnostics, LLCCJE2018-11-28
00380740135164AlinityAbbott GmbHCJE2018-06-06
00380740135171AlinityAbbott GmbHCJE2018-06-06
00852169008027ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP)CLEARCHEM DIAGNOSTICS INC.CJE2018-04-30
00380740150891ARCHITECTAbbott GmbHCJE2017-05-30
00380740150907ARCHITECTAbbott GmbHCJE2017-05-30
00817274022436JAS DiagnosticsDREW SCIENTIFIC, INC.CJE2017-03-23
00817274022443JAS DiagnosticsDREW SCIENTIFIC, INC.CJE2017-03-23
05060500091699Synermed®INFRARED LABORATORY SYSTEMS LLCCJE2017-02-28
00817302023015CAROLINA LIQUID CHEMISTRIES CORP.® ALP REAGENT PRODUCT NO. DT206CAROLINA LIQUID CHEMISTRIES CORPORATIONCJE2016-10-17
00812137011855Alkaline Phosphatase Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.CJE2016-10-12
00817439020123Alkaline Phos/ BS480Medtest Dx, Inc.CJE2016-09-27
00817439020130ALP ReagentMedtest Dx, Inc.CJE2016-09-27
00817439020147MedTest DX Alkaline PhosphataseMedtest Dx, Inc.CJE2016-09-27
15099590000028AUBeckman Coulter, Inc.CJE2016-09-24
15099590010034AUBeckman Coulter, Inc.CJE2016-09-24
15099590020019AUBeckman Coulter, Inc.CJE2016-09-24
15099590060015AUBeckman Coulter, Inc.CJE2016-09-24