ABX Pentra N MultiControl 1300054414

GUDID 03610230009055

HORIBA ABX SAS

Multiple clinical chemistry protein IVD, control
Primary Device ID03610230009055
NIH Device Record Keyf10902bc-3716-4ab1-9736-ecde2c727128
Commercial Distribution StatusIn Commercial Distribution
Brand NameABX Pentra N MultiControl
Version Model Number1300054414
Catalog Number1300054414
Company DUNS273647420
Company NameHORIBA ABX SAS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103610230009055 [Primary]

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-26
Device Publish Date2020-05-18

Devices Manufactured by HORIBA ABX SAS

03610230004623 - ABX CLEANER (0.5L)2026-02-24
03610230009932 - ABX Micros 602026-02-02
03610230005774 - ABX PENTRA MICRO-ALB CAL2025-08-18
03610230005781 - ABX PENTRA MICRO ALB CONTROL L/H2025-08-18
03610230008232 - ABX Pentra Micro ALB 2 Cal2025-08-18
03610230008966 - Yumizen P80002025-07-15 1 connexion
03610230009444 - Yumizen H25002024-12-09
03610230009451 - Yumizen H25002024-12-09

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