Yumizen C1200 Prealbumin

GUDID 03610230007396

HORIBA ABX SAS

Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry
Primary Device ID03610230007396
NIH Device Record Key7e5a2177-42ae-4db8-9c01-313682370124
Commercial Distribution StatusIn Commercial Distribution
Brand NameYumizen C1200 Prealbumin
Version Model Number1300023887
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
GS103610230007396 [Primary]

FDA Product Code

JZJPrealbumin, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-08
Device Publish Date2020-08-31

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