Yumizen C1200 RF Cal

GUDID 03610230007600

HORIBA ABX SAS

Rheumatoid factor IVD, calibrator Rheumatoid factor IVD, calibrator Rheumatoid factor IVD, calibrator Rheumatoid factor IVD, calibrator Rheumatoid factor IVD, calibrator Rheumatoid factor IVD, calibrator Rheumatoid factor IVD, calibrator Rheumatoid factor IVD, calibrator Rheumatoid factor IVD, calibrator Rheumatoid factor IVD, calibrator Rheumatoid factor IVD, calibrator Rheumatoid factor IVD, calibrator Rheumatoid factor IVD, calibrator Rheumatoid factor IVD, calibrator
Primary Device ID03610230007600
NIH Device Record Keyde57851f-dfe9-46da-85ee-7b247136c3da
Commercial Distribution StatusIn Commercial Distribution
Brand NameYumizen C1200 RF Cal
Version Model Number1300023908
Company DUNS273647420
Company NameHORIBA ABX SAS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103610230007600 [Primary]

FDA Product Code

JITCalibrator, Secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-22
Device Publish Date2020-09-14

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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