Access DHEA-S Calibrators A10827

GUDID 15099590201449

The Access DHEA-S Calibrators are intended to calibrate the Access DHEA-S assay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.

Beckman Coulter, Inc.

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Primary Device ID15099590201449
NIH Device Record Keyb2905ddd-c9c0-4b81-8e43-7f6b2c6c4656
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess DHEA-S Calibrators
Version Model NumberA10827
Catalog NumberA10827
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
GS115099590201449 [Primary]

FDA Product Code

JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

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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