Yumizen C1200 Micro Alb U/CSF Cal Normal

GUDID 03610230007464

HORIBA ABX SAS

Albumin IVD, calibrator Albumin IVD, calibrator Albumin IVD, calibrator Albumin IVD, calibrator Albumin IVD, calibrator Albumin IVD, calibrator Albumin IVD, calibrator Albumin IVD, calibrator Albumin IVD, calibrator Albumin IVD, calibrator Albumin IVD, calibrator Albumin IVD, calibrator Albumin IVD, calibrator
Primary Device ID03610230007464
NIH Device Record Key34f69b87-923e-4f8a-b836-8323b1511078
Commercial Distribution StatusIn Commercial Distribution
Brand NameYumizen C1200 Micro Alb U/CSF Cal Normal
Version Model Number1300023894
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
GS103610230007464 [Primary]
GS103610230007464 [Primary]
GS103610230007464 [Primary]
GS103610230007464 [Primary]
GS103610230007464 [Primary]
GS103610230007464 [Primary]
GS103610230007464 [Primary]
GS103610230007464 [Primary]
GS103610230007464 [Primary]
GS103610230007464 [Primary]
GS103610230007464 [Primary]
GS103610230007464 [Primary]
GS103610230007464 [Primary]

FDA Product Code

JISCalibrator, Primary
JISCalibrator, Primary
JISCalibrator, Primary
JISCalibrator, Primary
JISCalibrator, Primary
JISCalibrator, Primary
JISCalibrator, Primary
JISCalibrator, Primary
JISCalibrator, Primary
JISCalibrator, Primary
JISCalibrator, Primary
JISCalibrator, Primary
JISCalibrator, Primary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-15
Device Publish Date2020-09-07

Devices Manufactured by HORIBA ABX SAS

03610230007877 - Yumizen C Urine Level 1 Control2020-09-24
03610230007884 - Yumizen C Urine Level 2 Control2020-09-24
03610230006801 - Yumizen C1200 ALT2020-09-22
03610230006856 - Yumizen C1200 AST2020-09-22
03610230007235 - Yumizen C1200 Albumin U/CSF2020-09-22
03610230007525 - Yumizen C1200 Cystatin C Cal2020-09-22
03610230007549 - Yumizen C1200 Ferritin Cal2020-09-22
03610230007600 - Yumizen C1200 RF Cal2020-09-22

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