ABX Pentra P MultiControl 1300054415

GUDID 03610230009062

HORIBA ABX SAS

Multiple clinical chemistry protein IVD, control
Primary Device ID03610230009062
NIH Device Record Keyfaf85f8a-25d5-4e04-92b6-090be21e09c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameABX Pentra P MultiControl
Version Model Number1300054415
Catalog Number1300054415
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
GS103610230009062 [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

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
03610230009611 - ABX Minocal2024-10-07

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.