Access Estradiol Calibrator S0 33546

GUDID 15099590231385

The Access Estradiol Calibrator S0 is intended for use with Access Estradiol assay to dilute patient samples containing analyte concentrations greater than the analyte specific S5 calibrator

Beckman Coulter, Inc.

Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID15099590231385
NIH Device Record Key947032e1-812b-4a9a-9ebe-fad0c9d3d6b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Estradiol Calibrator S0
Version Model Number33546
Catalog Number33546
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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
GS115099590231385 [Primary]

FDA Product Code

JITCalibrator, Secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-01
Device Publish Date2021-09-23

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