Elecsys FSH 08932352190

GUDID 07613336170373

Roche Diagnostics GmbH

Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Primary Device ID07613336170373
NIH Device Record Keyee9ad6d0-c007-4293-b841-93bec0624479
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys FSH
Version Model Number08932352190
Catalog Number08932352190
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336170373 [Primary]

FDA Product Code

CGJRADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-14
Device Publish Date2021-10-06

On-Brand Devices [Elecsys FSH]

0401563090922311775863122
0761333617038008932387190
0761333617037308932352190
0761333621780109745840190

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