ABX PENTRA MICRO ALB CONTROL L/H

GUDID 03610230005781

HORIBA ABX SAS

Albumin IVD, control
Primary Device ID03610230005781
NIH Device Record Key2230632a-a960-4728-9f2d-82f0c5b4b71c
Commercial Distribution StatusIn Commercial Distribution
Brand NameABX PENTRA MICRO ALB CONTROL L/H
Version Model Number1220001967
Company DUNS273647420
Company NameHORIBA ABX SAS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103610230005781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-08-18
Device Publish Date2016-08-16

Devices Manufactured by HORIBA ABX SAS

03610230005774 - ABX PENTRA MICRO-ALB CAL2025-08-18
03610230005781 - ABX PENTRA MICRO ALB CONTROL L/H2025-08-18
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
03610230008584 - BFTROL2024-10-04 BF Hematology control

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