Elecsys Rubella IgM 09755837190

GUDID 07613336218440

Roche Diagnostics GmbH

Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Primary Device ID07613336218440
NIH Device Record Keyab07c152-6d3f-4c60-b6ff-8d21589eb54e
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys Rubella IgM
Version Model Number09755837190
Catalog Number09755837190
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 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
GS107613336218440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFXENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-01
Device Publish Date2024-10-24

Devices Manufactured by Roche Diagnostics GmbH

07613336182994 - PreciControl Release HBsAg II2024-11-15
07613336228456 - Elecsys HBsAg II2024-11-15
07613336183137 - Elecsys HBsAg II Auto Confirm2024-11-15
07613336183168 - PreciControl HBsAg II2024-11-15
07613336183236 - PreciControl HBsAg II Auto Confirm2024-11-15
07613336234402 - navify® Lab Operations2024-11-05
07613336217665 - Elecsys Total PSA2024-11-01
07613336217672 - Elecsys free PSA2024-11-01

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