FDA.reportPublic FDA data

ABX PENTRA CALCIUM AS CP

Primary DI
03610230005750
Brand
ABX PENTRA CALCIUM AS CP
Company
HORIBA ABX SAS
Model
1220001954
Published
2016-08-23
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
CJYAzo Dye, Calcium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJYAzo Dye, CalciumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123171000ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONTHORIBA ABX SAS2013-07-03CJY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610230005750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610230005750036102300057503610230005750

GMDN Terms#

Term, Definition table
TermDefinition
Calcium (Ca2+) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of calcium (Ca2+) in a clinical specimen, using a spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
273647420
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610230004883ABX PENTRA IMMUNO II CONTROL L/H12200016222016-08-23
03610230004623ABX CLEANER (0.5L)12109030112016-08-16
03610230009932ABX Micros 6013001465762026-01-23
03610230009444Yumizen H250013001021472024-11-29
03610230009451Yumizen H250013001021482024-11-29
03610230005774ABX PENTRA MICRO-ALB CAL12200019662016-09-05
03610230005781ABX PENTRA MICRO ALB CONTROL L/H12200019672016-08-16
03610230008232ABX Pentra Micro ALB 2 Cal13000325652017-07-07
03610230005187ABX PENTRA ALBUMIN CP12200016642016-08-23
03610230005767ABX PENTRA MICRO ALBUMIN CP12200019652016-08-16
03610230008225ABX Pentra Micro ALBUMIN 2 CP13000325632017-06-27
03610230007235Yumizen C1200 Albumin U/CSF13000238712020-09-14
03610230007464Yumizen C1200 Micro Alb U/CSF Cal Normal 1300023894 2020-09-07
03610230007891Yumizen C1200 U/CSF L1 Micro Alb Control 1300023948 2020-09-07
03610230007914Yumizen C1200 U/CSF L2 Micro Alb Control 1300023949 2020-09-07
03610230006825Yumizen C1200 Albumin13000237992020-05-06
03610230008966Yumizen P800013000333272025-07-07
03610230009611ABX Minocal530010030053001003002024-09-27
03610230008584BFTROL13000394052024-09-26
03610230009581ABX Minotrol 16530010031253001003122024-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03610230008607Yumizen C1200 Calcium ASHORIBA ABX SASCJY2020-05-06
00380740161491ARCHITECTAbbott GmbHCJY2020-03-09
00380740161507ARCHITECTAbbott GmbHCJY2020-03-09
00380740161514ARCHITECTAbbott GmbHCJY2020-03-09
10758750031795VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CJY2019-11-13
05055273208368CALCIUM (Ca)RANDOX LABORATORIES LIMITEDCJY2019-06-03
00386100002060Ca Reagent Kit MEDICA CORPORATIONCJY2019-02-14
00630414220697Atellica CH CA_2Siemens Healthcare Diagnostics Inc.CJY2018-09-24
00380740135409AlinityAbbott GmbHCJY2018-08-31
00380740132613AlinityAbbott GmbHCJY2018-08-08
00817274022450JAS DiagnosticsDREW SCIENTIFIC, INC.CJY2017-04-04
05060500091835Synermed®INFRARED LABORATORY SYSTEMS LLCCJY2017-02-28
00817302023091CAROLINA LIQUID CHEMISTRIES CORP.® CA REAGENT PRODUCT NO. DT251CAROLINA LIQUID CHEMISTRIES CORPORATIONCJY2016-10-17
15099590000325AUBeckman Coulter, Inc.CJY2016-09-24
15099590011086AUBeckman Coulter, Inc.CJY2016-09-24
15099590060183AUBeckman Coulter, Inc.CJY2016-09-24
00857969006105ACEALFA WASSERMANN, INC.CJY2016-09-24
00630414513096ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III)Siemens Healthcare Diagnostics Inc.CJY2016-09-24
00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)Siemens Healthcare Diagnostics Inc.CJY2016-09-24
00630414553160ADVIA® Chemistry CA_2c Calcium_2 Reagents, Concentrated - Arsenazo IIISiemens Healthcare Diagnostics Inc.CJY2016-09-24
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EABA40000291Piccolo General Chemistry 13ABAXIS, INC.CJY2016-09-23
EABA40000311Piccolo Basic Metabolic Panel PlusABAXIS, INC.CJY2016-09-23
EABA40000351Piccolo BioChemistry Panel PlusABAXIS, INC.CJY2016-09-23
EABA40000371Piccolo MetLac 12 PanelABAXIS, INC.CJY2016-09-23
EABA40000411Piccolo AmLyte 13ABAXIS, INC.CJY2016-09-23
00657498000618Calcium (Arsenazo) LiquiColor®STANBIO LABORATORY, L.P.CJY2016-09-23
00657498001462Sirrus® Calcium LiquiColor®STANBIO LABORATORY, L.P.CJY2016-09-23