PENTRA C200 STANDARD

GUDID 03610230006689

HORIBA ABX SAS

Multiple clinical chemistry analyser IVD, laboratory, automated
Primary Device ID03610230006689
NIH Device Record Key9f1a714b-83f3-4759-a10b-44313b38daf8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePENTRA C200 STANDARD
Version Model Number1280090005
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
GS103610230006689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

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

Devices Manufactured by HORIBA ABX SAS

03610230005545 - ABX PENTRA CK CONTROL2024-07-18
03610230005392 - ABX PENTRA HBA1C WB2024-07-16
03610230005408 - ABX PENTRA HBA1C WB CAL2024-07-16
03610230005415 - ABX PENTRA HBA1C WB CONTROL2024-07-16
03610230005460 - ABX PENTRA HBA1C WB HEMOLYSIS REAGENT2024-07-16
03610230008157 - NUCEDIFF (1L)2024-06-07
03610230008508 - Yumizen SPS2024-06-07
03610230008928 - Yumizen T60002024-06-07 Right module SPS only

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