ABX Micros 60

GUDID 03610230009932

HORIBA ABX SAS

Haematological cell analyser IVD
Primary Device ID03610230009932
NIH Device Record Keyc3df4cda-c028-4417-885e-d3720362e9b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameABX Micros 60
Version Model Number1300146576
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103610230009932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, Differential Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-02
Device Publish Date2026-01-23

Devices Manufactured by HORIBA ABX SAS

03610230009932 - ABX Micros 602026-02-02
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

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