Access hLH 33510

GUDID 15099590232276

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 Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590232276
NIH Device Record Keyed2f1469-06cf-4a6a-9a48-ec29ce60a125
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
GS115099590232276 [Primary]

FDA Product Code

CEPRadioimmunoassay, Luteinizing Hormone
JITCalibrator, Secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-04
Device Publish Date2023-06-26

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