Elecsys FSH 11775863122

GUDID 04015630909223

Roche Diagnostics GmbH

Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Primary Device ID04015630909223
NIH Device Record Keya9c0bc5d-705c-45b2-945b-c5b6dc537fdf
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys FSH
Version Model Number11775863122
Catalog Number11775863122
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
GS104015630909223 [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 Date2020-03-23
Device Publish Date2020-03-13

On-Brand Devices [Elecsys FSH]

0401563090922311775863122
0761333617038008932387190
0761333617037308932352190
0761333621780109745840190

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