AU OSR6164

GUDID 15099590010614

Ceruloplasmin Reagent

Beckman Coulter, Inc.

Ceruloplasmin IVD, kit, nephelometry/turbidimetry
Primary Device ID15099590010614
NIH Device Record Keyd1d1935e-e0c2-49ef-a14c-280408de2625
Commercial Distribution StatusIn Commercial Distribution
Brand NameAU
Version Model NumberOSR6164
Catalog NumberOSR6164
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
GS115099590010614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DDBCeruloplasmin, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-17

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15099590635565URINE CREATININE CALIBRATOR
15099590635534URINE CHEMISTRY CALIBRATOR
15099590140076ISE Buffer Solution
15099590140069ISE Mid Standard Solution
15099590140052ISE Reference Solution
15099590140045ISE Low Serum Standard
15099590140038ISE High Serum Standard
15099590140021ISE Low/High Urine Standard
15099590140014ISE Internal Reference Solution
15099590140007ISE Na+/K+ Selectivity Check Solution
15099590080884D-Dimer Calibrator
15099590080860Wash Solution
15099590080839Prealbumin Calibrator
15099590080785Serum Protein Multi-Calibrator 2
15099590080778APO A1 & B Calibrator
15099590080761Serum Protein Multi-Calibrator 1
15099590070588D-Dimer Control
15099590070571RF Latex Calibrator
15099590070564CRP Latex Calibrator Highly Sensitive (HS) Set
15099590070557CRP Latex Calibrator Normal (N) Set
15099590070519LDL Cholesterol Calibrator
15099590070502HDL Cholesterol Calibrator
15099590060213Urea Stat/Urea Nitrogen Stat
15099590060206Bicarbonate
15099590060183Calcium Arsenazo
15099590060176Total Bilirubin
15099590060169Direct Bilirubin
15099590060152Uric Acid
15099590060145Triglyceride
15099590060114Urea/Urea Nitrogen
15099590060091Total Protein
15099590060084Glucose
15099590060077Creatinine
15099590060060Cholesterol
15099590060039AST
15099590060022ALT
15099590060015ALP
15099590060008Albumin
15099590050405Urea Stat/Urea Nitrogen Stat
15099590050085AST
15099590020422Urine CSF Albumin
15099590020408LIH
15099590020385Uric Acid
15099590020361LDL-Cholesterol
15099590020354HDL-Cholesterol
15099590020347Urinary/CSF Protein
15099590020279Iron
15099590020262CK (NAC)
15099590020187Bicarbonate

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