Yumizen C1200 Cholesterol

GUDID 03610230006917

HORIBA ABX SAS

Total cholesterol lipid IVD, kit, enzyme spectrophotometry Total cholesterol lipid IVD, kit, enzyme spectrophotometry Total cholesterol lipid IVD, kit, enzyme spectrophotometry Total cholesterol lipid IVD, kit, enzyme spectrophotometry Total cholesterol lipid IVD, kit, enzyme spectrophotometry Total cholesterol lipid IVD, kit, enzyme spectrophotometry Total cholesterol lipid IVD, kit, enzyme spectrophotometry Total cholesterol lipid IVD, kit, enzyme spectrophotometry Total cholesterol lipid IVD, kit, enzyme spectrophotometry Total cholesterol lipid IVD, kit, enzyme spectrophotometry Total cholesterol lipid IVD, kit, enzyme spectrophotometry Total cholesterol lipid IVD, kit, enzyme spectrophotometry Total cholesterol lipid IVD, kit, enzyme spectrophotometry
Primary Device ID03610230006917
NIH Device Record Keye1c7a1dc-c0c5-4872-b555-8d16e74a1d1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameYumizen C1200 Cholesterol
Version Model Number1300023838
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
GS103610230006917 [Primary]
GS103610230006917 [Primary]
GS103610230006917 [Primary]
GS103610230006917 [Primary]
GS103610230006917 [Primary]
GS103610230006917 [Primary]
GS103610230006917 [Primary]
GS103610230006917 [Primary]
GS103610230006917 [Primary]
GS103610230006917 [Primary]
GS103610230006917 [Primary]
GS103610230006917 [Primary]
GS103610230006917 [Primary]

FDA Product Code

CHHEnzymatic Esterase--Oxidase, Cholesterol
CHHEnzymatic Esterase--Oxidase, Cholesterol
CHHEnzymatic Esterase--Oxidase, Cholesterol
CHHEnzymatic Esterase--Oxidase, Cholesterol
CHHEnzymatic Esterase--Oxidase, Cholesterol
CHHEnzymatic Esterase--Oxidase, Cholesterol
CHHEnzymatic Esterase--Oxidase, Cholesterol
CHHEnzymatic Esterase--Oxidase, Cholesterol
CHHEnzymatic Esterase--Oxidase, Cholesterol
CHHEnzymatic Esterase--Oxidase, Cholesterol
CHHEnzymatic Esterase--Oxidase, Cholesterol
CHHEnzymatic Esterase--Oxidase, Cholesterol
CHHEnzymatic Esterase--Oxidase, Cholesterol

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

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
03610230007624 - Yumizen C1200 CO2 Cal2020-09-22
03610230007853 - Yumizen C1200 Level 1 Protein Control2020-09-22

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