Elecsys SHBG 3052001160

GUDID 04015630939305

Roche Diagnostics GmbH

Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
Primary Device ID04015630939305
NIH Device Record Key15e7fb66-6978-40c0-943d-72458d3b950a
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys SHBG
Version Model Number3052001160
Catalog Number3052001160
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630939305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDZRADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-28
Device Publish Date2021-01-20

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