Yumizen C1200 AL 3200675839/3200685493

GUDID 03610230009253

AC 220V Class2 Laser Product + AC100V This device is a combination between the Yumizen C1200 (CA-20151BM6010C) and the autoloader RAmini (CA-21391RAMINI).

HORIBA ABX SAS

Multiple clinical chemistry analyser IVD, laboratory
Primary Device ID03610230009253
NIH Device Record Key705344e2-edcd-4f32-9dfb-6e09892d2ff9
Commercial Distribution StatusIn Commercial Distribution
Brand NameYumizen C1200 AL
Version Model NumberCA-20151BM6010C/CA-21391RAMINI
Catalog Number3200675839/3200685493
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
GS103610230009253 [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 Number2
Public Version Date2022-09-16
Device Publish Date2021-02-16

Devices Manufactured by HORIBA ABX SAS

03610230009444 - Yumizen H25002024-12-09
03610230009451 - Yumizen H25002024-12-09
03610230009611 - ABX Minocal2024-10-07
03610230008584 - BFTROL2024-10-04 BF Hematology control
03610230009581 - ABX Minotrol 162024-10-03
03610230009598 - ABX Minotrol 162024-10-03
03610230009604 - ABX Minotrol 162024-10-03
03610230005545 - ABX PENTRA CK CONTROL2024-07-18

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