Access CEA Diluent 33206

GUDID 15099590624828

The Access CEA Diluent (BSA matrix) is intended for use with the Access CEA assay to dilute patient samples containing CEA concentrations greater than

Beckman Coulter, Inc.

Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590624828
NIH Device Record Keyc6546811-7615-41d4-ad00-10356c559e92
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess CEA Diluent
Version Model Number33206
Catalog Number33206
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590624828 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DHXSystem, Test, Carcinoembryonic Antigen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-09

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