IMMAGE 474620

GUDID 15099590227029

IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent

Beckman Coulter, Inc.

Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody Total immunoglobulin E (IgE total) IVD, antibody
Primary Device ID15099590227029
NIH Device Record Key58f32554-a9f9-4dd7-a1ec-3a32a02fbbed
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMMAGE
Version Model Number474620
Catalog Number474620
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS115099590227029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
DGCIge, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-22
Device Publish Date2016-08-24

On-Brand Devices [IMMAGE]

15099590575342IMMAGE Immunochemistry Systems DIL 2 Diluent 2
15099590575335IMMAGE Immunochemistry Systems DIL 1 Diluent 1
15099590575328IMMAGE Immunochemistry Systems BUF 1 Buffer 1
15099590575298IMMAGE Immunochemistry Systems BUF 2 Buffer 2
15099590575137Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator
15099590233242IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent
15099590232634Immunochemistry Systems CAL 2 Calibrator 2
15099590231910IMMAGE Immunochemistry Systems CRP C-Reactive Protein Reagent
15099590231903IMMAGE Immunochemistry Systems BUF 4 Buffer 4
15099590231897IMMAGE Immunochemistry Systems PAB Prealbumin Reagent
15099590231712IMMAGE Immunochemistry Systems Wash Solution
15099590230494IMMAGE Immunochemistry Systems KAP Kappa Light Chain Reagent
15099590230487IMMAGE Immunochemistry Systems C3 Complement C3 Reagent
15099590230470IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent
15099590230463IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent
15099590230456IMMAGE Immunochemistry Systems HPT Haptoglobin Reagent
15099590230449IMMAGE Immunochemistry Systems C4 Complement C4 Reagent
15099590227043IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator
15099590227029IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent
15099590227005IMMAGE Immunochemistry Systems CRPH High Sensitivity CRP Reagent
15099590226985IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent
15099590226961IMMAGE Immunochemistry Systems BUF 3 Buffer 3
15099590226947IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent
15099590225384Immunochemistry Systems Level 1 Urine Protein Control
15099590224158Immunochemistry Systems Level 2 Urine Protein Control
15099590224080IMMAGE Immunochemistry Systems CER Ceruloplasmin Reagent
15099590224073IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent
15099590224066IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent
15099590224059IMMAGE Immunochemistry Systems AMG Alpha-2-Macroglobulin Reagent
15099590224042IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent
15099590224035IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent
15099590224028IMMAGE Immunochemistry Systems AT3 Antithrombin III Reagent
15099590223885IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent
15099590223878IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent
15099590223373IMMAGE Immunochemistry Systems FER Ferritin Reagent
15099590223250Immunochemistry Systems CAL 3 Calibrator 3
15099590223243IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator
15099590222673Immunochemistry Systems UCAL Urine Protein Calibrator
15099590221225IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A
15099590221218IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M
15099590221201IMMAGE Immunochemistry Systems ALB Albumin Reagent
15099590221195IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent
15099590221188IMMAGE Immunochemistry Systems ASO Anti-Streptolysin Reagent
15099590221171IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent
15099590203160IMMAGE Immunochemistry Systems CCRP High Sensitivity Cardiac CRP Reagent
15099590200060Immunochemistry Systems CAL 1 Calibrator 1
15099590180171IMMAGE Immunochemistry Systems TRF Transferrin Reagent
15099590180164IMMAGE Immunochemistry Systems MA Microalbumin Reagent
15099590180157IMMAGE Immunochemistry Systems TRU Urine Transferrin Reagent
15099590180140IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent

Trademark Results [IMMAGE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMMAGE
IMMAGE
74649133 2101862 Live/Registered
BECKMAN COULTER, INC
1995-03-20
IMMAGE
IMMAGE
74631264 not registered Dead/Abandoned
Howell, Howard O.
1995-02-07

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