FDA.reportPublic FDA data

ALKALINE PHOSPHATASE (ALP)

Primary DI
05055273208207
Brand
ALKALINE PHOSPHATASE (ALP)
Company
RANDOX LABORATORIES LIMITED
Model
AP8302
Published
2019-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
05055273208207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273208207050552732082075055273208207

GMDN Terms#

Term, Definition table
TermDefinition
Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple alkaline phosphatase (ALP) isoenzymes in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
227530649
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
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03

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
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
00857969006297ACEALFA WASSERMANN, INC.CJE2016-09-24