ABX PENTRA 60C+

GUDID 03610230006429

ABX PENTRA 60C+ (110V)

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 ID03610230006429
NIH Device Record Keyeefcc3a7-2b10-4d3e-8f94-7f809c033b56
Commercial Distribution StatusIn Commercial Distribution
Brand NameABX PENTRA 60C+
Version Model Number1280120005, 1280120007, 1280120009, 1280120011
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
GS103610230006429 [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 60C+]

03610230006429ABX PENTRA 60C+ (110V)
036102300060091280120006, 1280120008

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