ABX PENTRA DX 120

GUDID 03610230005989

ABX PENTRA DX 120 (110V), ABX PENTRA DX 120 (220V)

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 ID03610230005989
NIH Device Record Key75d0278e-deb9-45d1-896a-732d782443f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameABX PENTRA DX 120
Version Model Number1280100123, 1280100137
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
GS103610230005989 [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 Date2016-09-02

On-Brand Devices [ABX PENTRA DX 120]

03610230006375100 or 110V, ready for SPS
03610230006368ABX PENTRA DX 120 (110V), ABX PENTRA DX 120 (100V)
03610230005989ABX PENTRA DX 120 (110V), ABX PENTRA DX 120 (220V)
03610230005972ABX PENTRA DX 120 (OCCASION)

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