Access hLH 33510

GUDID 15099590575243

The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.

Beckman Coulter, Inc.

Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590575243
NIH Device Record Key821a2b0f-cec6-44c4-b251-6c2a01d900cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess hLH
Version Model Number33510
Catalog Number33510
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
GS115099590575243 [Primary]

FDA Product Code

CEPRadioimmunoassay, Luteinizing Hormone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-01
Device Publish Date2024-04-23

On-Brand Devices [Access hLH]

15099590232276The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitati
15099590575243The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitati

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