FDA.reportPublic FDA data

IDG/Sanzay

Primary DI
00850053916076
Brand
IDG/Sanzay
Company
IDG/SANZAY Corporation
Model
1
Catalog number
C105
Device description
For the quantitative determination of calcium concentration in serum or plasma.
Published
2024-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
CICCresolphthalein Complexone, Calcium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CICCresolphthalein Complexone, CalciumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921625000CALCIUM-ARSENAZO III REAGENT SETPointe Scientific, Inc.,1992-05-13CIC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053916076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053916076008500539160768500539160760850053916076

GMDN Terms#

Term, Definition table
TermDefinition
Calcium (Ca2+) 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 calcium (Ca2+) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume100Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
948875013
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
00850053916090IDG/Sanzay1C1532024-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654041Atellica CH CaSiemens Healthcare Diagnostics Inc.CIC2026-04-08
10673486001365Teco Diagnostics Calcium Reagent SetTECO DIAGNOSTICSCIC2023-07-25
00811727016065Pointe Calcium ReagentHORIBA INSTRUMENTS INCORPORATEDCIC2021-01-30
00630414550916ADVIA® Chemistry Multi-Drug Urine Controls 1,2Siemens Healthcare Diagnostics Inc.CIC2020-09-24
00811727015754Pointe Calcium Arsenazo for BS480HORIBA INSTRUMENTS INCORPORATEDCIC2020-05-28
00852169008119ClearChem Diagnostics Inc. CalciumCLEARCHEM DIAGNOSTICS INC.CIC2018-04-30
00630414595672Atellica CH CaSiemens Healthcare Diagnostics Inc.CIC2017-12-21
00817274022559JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2017-06-09
00812137011923Calcium Arsenazo III ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIC2016-10-12
00817439020345Calcium / BS480Medtest Dx, Inc.CIC2016-09-27
15099590010126AUBeckman Coulter, Inc.CIC2016-09-24
15099590020057AUBeckman Coulter, Inc.CIC2016-09-24
00842768014123Dimension® Flex® reagent cartridge CASiemens Healthcare Diagnostics Inc.CIC2016-09-24
00842768015618Dimension Vista® Flex® reagent cartridge CASiemens Healthcare Diagnostics Inc.CIC2016-09-24
00657498000625Calcium (CPC) LiquiColor®STANBIO LABORATORY, L.P.CIC2016-09-24
00630414508405ADVIA® Chemistry Calcium ReagentsSiemens Healthcare Diagnostics Inc.CIC2016-09-24
00630414538716ADVIA® Chemistry Calcium Reagents, Concentrated (CA_c)-CPCSiemens Healthcare Diagnostics Inc.CIC2016-09-24
00630414555904ADVIA® Chemistry CPC Calcium ReagentsSiemens Healthcare Diagnostics Inc.CIC2016-09-24
04015630901999CalciumRoche Diagnostics GmbHCIC2016-09-20
04015630921348CalciumRoche Diagnostics GmbHCIC2016-09-20
04015630921355CalciumRoche Diagnostics GmbHCIC2016-09-20
05060500090432Synermed®INFRARED LABORATORY SYSTEMS LLCCIC2016-09-20
05060500090449Synermed®INFRARED LABORATORY SYSTEMS LLCCIC2016-09-20
05060500090456Synermed®INFRARED LABORATORY SYSTEMS LLCCIC2016-09-20
05055273200898CaRANDOX LABORATORIES LIMITEDCIC2016-09-16
05055273200911CaRANDOX LABORATORIES LIMITEDCIC2016-09-16
05055273200928CaRANDOX LABORATORIES LIMITEDCIC2016-09-16
00817274021088JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2016-09-09
00817274021095JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2016-09-09
00817274021101JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2016-09-09