ABX MICROS ES 60

GUDID 03610230006115

HORIBA ABX SAS

Haematological cell analyser IVD, automated Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD
Primary Device ID03610230006115
NIH Device Record Key665f5ec3-07a6-4855-9d89-40f3c75e1ca3
Commercial Distribution StatusIn Commercial Distribution
Brand NameABX MICROS ES 60
Version Model Number1280200072
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 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
GS103610230006115 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2016-05-02

Devices Manufactured by HORIBA ABX SAS

03610230004890 - ABX PENTRA ALP CP2023-07-06
03610230004913 - ABX PENTRA AMYLASE CP2023-07-06
03610230004920 - ABX PENTRA AST CP2023-07-06
03610230004937 - ABX PENTRA GGT CP2023-07-06
03610230004944 - ABX PENTRA LIPASE CP2023-07-06
03610230004975 - ABX PENTRA CHOLESTEROL CP2023-07-06
03610230004982 - ABX PENTRA BILIRUBIN, DIRECT CP2023-07-06
03610230004999 - ABX PENTRA HDL DIRECT CP2023-07-06

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