FDA.reportPublic FDA data

Calcium (CPC) LiquiColor®

Primary DI
00657498000625
Brand
Calcium (CPC) LiquiColor®
Company
STANBIO LABORATORY, L.P.
Model
0150-250
Catalog number
0150-250
Device description
For the Quantitative Colorimetric determination of Total Calcium in serum, plasma or urine.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CICCresolphthalein Complexone, Calcium

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00657498000625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498000625006574980006256574980006250657498000625

GMDN Terms#

Term, Definition table
TermDefinition
Calcium (Ca2+) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of calcium (Ca2+) in a clinical specimen, using a 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
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
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
00657498001950Procalcitonin LiquiColor2300-0602300-0602017-06-26
00657498000434Albumin LiquiColor®0285-5000285-5002016-09-23
00657498001516Sirrus® Albumin LiquiColor®S0285-750S0285-7502016-09-23
00657498000847Glycated Serum Protein (GSP) LiquiColor®2350-0622350-0622016-09-23
00657498002179STAT-Site WB Dual Analyte Measurement System7000-0017000-0012019-11-18
00657498002193STAT-Site WB Blood Glucose Test Strips7010-0257010-0252019-11-18
00657498002209STAT-Site WB Blood Glucose Test Strips7010-0507010-0502019-11-18
00657498002216STAT-Site WB Blood Glucose Test Strips7010-1007010-1002019-11-18
00657498002230STAT-Site WB B-Ketone Test Strips7020-0257020-0252019-11-18
00657498002247STAT-Site WB B-Ketone Test Strips7020-0507020-0502019-11-18
00657498002254STAT-Site WB B-Ketone Test Strips7020-1007020-1002019-11-18
00657498002261Blood Glucose Control Solution7014-2047014-2042019-11-18
00657498002278B-Ketone Control Solution7024-2047024-2042019-11-18
00657498000427Acetaminophen Liquicolor®2400-0602400-0602016-09-23
00657498000441Alkaline Phosphatase LiquiColor®2900-4302900-4302016-09-23
00657498000458Alkaline Phosphatase LiquiColor®2900-5002900-5002016-09-23
00657498000489a-Amylase LiquiColor®2970-4302970-4302016-09-23
00657498000496AST/SGOT Liqui-UV®2920-4302920-4302016-09-23
00657498000502AST/SGOT Liqui-UV®2920-5002920-5002016-09-23
00657498000519B-Hydroxybutyrate LiquiColor®2440-0582440-0582016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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