Yumizen C1200 HDL Cal

GUDID 03610230009307

HORIBA ABX SAS

High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator
Primary Device ID03610230009307
NIH Device Record Key307624e2-2697-4327-8644-88d254e3f66e
Commercial Distribution StatusIn Commercial Distribution
Brand NameYumizen C1200 HDL Cal
Version Model Number1300076290
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 Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103610230009307 [Primary]
GS103610230009307 [Primary]
GS103610230009307 [Primary]
GS103610230009307 [Primary]

FDA Product Code

JITCalibrator, Secondary
JITCalibrator, Secondary
JITCalibrator, Secondary
JITCalibrator, Secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

Devices Manufactured by HORIBA ABX SAS

03610230007044 - Yumizen C1200 HDL Direct2020-11-10
03610230009284 - Yumizen C1200 Level 1 CRPhs Control2020-11-10
03610230009291 - Yumizen C1200 Level 2 CRPhs Control2020-11-10
03610230009307 - Yumizen C1200 HDL Cal2020-11-10
03610230009307 - Yumizen C1200 HDL Cal2020-11-10
03610230009314 - Yumizen C1200 LDL Cal2020-11-10
03610230007877 - Yumizen C Urine Level 1 Control2020-09-24
03610230007884 - Yumizen C Urine Level 2 Control2020-09-24
03610230006801 - Yumizen C1200 ALT2020-09-22

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