FDA.reportPublic FDA data

ABX RETIX (0.5L)

Primary DI
03610230004630
Brand
ABX RETIX (0.5L)
Company
HORIBA ABX SAS
Model
1210904005
Published
2016-08-16
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
LEDStains, Chemical Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEDStains, Chemical SolutionHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610230004630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610230004630036102300046303610230004630

GMDN Terms#

Term, Definition table
TermDefinition
Differentiation solution IVDA differentiation solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.

Regulatory Flags#

DUNS number
273647420
Device count
1
Premarket exempt
true
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
00630414290010Atellica HEMA RET/PLTOSiemens Healthcare Diagnostics Inc.LED2026-02-06
00630414312484Atellica HEMA RET/PLTOSiemens Healthcare Diagnostics Inc.LED2026-02-06
00613647028643FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LED2025-04-30
20613647028647FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LED2025-04-30
00673693089746EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693089920EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693089944EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693089968EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693201247EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693201995EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693202015EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693202237EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693202244EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693202268EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693202299EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693202312EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693089647EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-05
00673693090063EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-05
00673693090209EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-05
00673693171175EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-04
00673693088084EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088091EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088114EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088121EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088138EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088145EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088152EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088176EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693228671EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693228688EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30