FDA.reportPublic FDA data

ABX PENTRA REFERENCE-E

Primary DI
03610230005866
Brand
ABX PENTRA REFERENCE-E
Company
HORIBA ABX SAS
Model
3014029451
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
JJPElectrode, Ion Selective (Non-Specified)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJPElectrode, Ion Selective (Non-Specified)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052007000ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)Horiba Abx2005-12-16CFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610230005866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610230005866036102300058663610230005866

GMDN Terms#

Term, Definition table
TermDefinition
Reference electrode IVDAn electrochemical sensor intended to be used as a known reference for electrical potential in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.

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
06936895300250BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJP2023-07-04
06936895300267BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJP2023-07-04
06936895300274BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJP2023-07-04
06936895300281BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJP2023-07-04
06936895301691BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJP2023-07-04
06936895301707BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJP2023-07-04
04987762129841Reference ElectrodeJEOL LTD.JJP2020-09-15
00853366007134PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.JJP2018-01-26
00853366007332PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.JJP2018-01-26
00853366007349PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.JJP2018-01-26