Access DHEA-S A10826

GUDID 15099590201432

The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.

Beckman Coulter, Inc.

C-peptide IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590201432
NIH Device Record Key3735a973-688c-4cab-922a-a9f3dd412684
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess DHEA-S
Version Model NumberA10826
Catalog NumberA10826
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
GS115099590201432 [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

Devices Manufactured by Beckman Coulter, Inc.

14987666545072 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
14987666545089 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
15099590742331 - DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
15099590209636 - DxH2024-11-19 Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood samples for histological stains and
15099590762889 - Stem-Kit Reagents2024-11-04 Stem-Kit Reagents
15099590762896 - StemTrol Control Cells2024-11-04 StemTrol Control Cells
15099590732103 - DxI 9000 Access Immunoassay Analyzer2024-10-28 The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or quali
15099590575243 - Access hLH2024-05-01 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing

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