Elecsys LH 11732234122

GUDID 04015630907410

Roche Diagnostics GmbH

Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Primary Device ID04015630907410
NIH Device Record Key8901aa5a-6104-4a88-9835-fefd85ead364
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys LH
Version Model Number11732234122
Catalog Number11732234122
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630907410 [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 Date2020-03-23
Device Publish Date2020-03-13

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