FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274020715
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
ALP2-120R1U
Device description
ALP R1 (1x 120mL) Unlabeled Vial
Published
2016-09-09
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
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
00817274020715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274020715008172740207158172740207150817274020715

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-305-324-2300Customerservice@erbadiagnostics.com

Regulatory Flags#

DUNS number
144968104
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
00817274020425Drew ScientificR12A24D-BUL2016-09-09
00817274021743JAS DiagnosticsA1CC1-0.52016-09-09
00817274021804JAS DiagnosticsLDH2-30R2U2016-09-12
00817274021811JAS DiagnosticsXL-LDH2-402016-09-12
00817274021828JAS DiagnosticsLDH2-120R1U2016-09-12
00817274021835JAS DiagnosticsLDH2-R1-BUL2016-09-12
00817274021842JAS DiagnosticsLDH2-R2-BUL2016-09-12
00817274021859JAS DiagnosticsDG-LDH2-1202016-09-12
00817274021866JAS DiagnosticsLDH2-1202016-09-12
00817274021873JAS DiagnosticsLDH2-1L2016-09-12
00817274020517Drew ScientificDSJ-9001-0012016-09-09
00817274020524DrewDSJ-9001-0212016-09-09
00817274021491JAS DiagnosticsBAS-9001-1812016-09-09
00817274022214JAS DiagnosticsTA1039802016-09-12
00817274022221JAS DiagnosticsTA1035772016-09-12
00817274020692JAS DiagnosticsALP2-1L2016-09-09
00817274020708JAS DiagnosticsXL-ALP2-402016-09-09
00817274020722JAS DiagnosticsALP2-30R2U2016-09-09
00817274020739JAS DiagnosticsALT2-P1L2016-09-09
00817274020746JAS DiagnosticsXL-ALT2-402016-09-09

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