FDA.reportPublic FDA data

IDG/Sanzay

Primary DI
00850053916014
Brand
IDG/Sanzay
Company
IDG/SANZAY Corporation
Model
1
Catalog number
C033
Device description
For the quantitative determination of alkaline phosphatase in human serum.
Published
2024-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00850053916014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053916014008500539160148500539160140850053916014

GMDN Terms#

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

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
948875013
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850053916212IDG/Sanzay1HCC12024-01-12
00850053916229IDG/Sanzay1HCC22024-01-12
00850053916007IDG/Sanzay1C0212023-12-18
00850053916205IDG/Sanzay1HC3012024-07-03
00850053916267IDG/Sanzay1QS012024-07-03
00850053916113IDG/Sanzay1C2432024-06-25
00850053916236IDG/Sanzay1QC012024-06-25
00850053916243IDG/Sanzay1QC022024-06-25
00850053916250IDG/Sanzay1QS31D2024-06-25
00850053916137IDG/Sanzay1C3432024-01-12
00850053916076IDG/Sanzay1C1052024-01-15
00850053916120IDG/Sanzay1C3212024-01-12
00850053916144IDG/Sanzay1C3912024-01-12
00850053916151IDG/Sanzay1C4032024-01-12
00850053916168IDG/Sanzay1C4132024-01-12
00850053916175IDG/Sanzay1C5012024-01-12
00850053916182IDG/Sanzay1HC1012024-01-12
00850053916199IDG/Sanzay1HC2012024-01-12
00850053916069IDG/Sanzay1C0952024-01-09
00850053916083IDG/Sanzay1C1232024-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00857969006297ACEALFA WASSERMANN, INC.CJE2016-09-24