Elecsys Syphilis 09015051190

GUDID 07613336171998

Syphilis Elecsys E2G 300 V2

Roche Diagnostics GmbH

Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay
Primary Device ID07613336171998
NIH Device Record Key45df632f-ae84-4038-9cb3-c8ed18bbbb73
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys Syphilis
Version Model Number09015051190
Catalog Number09015051190
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
GS107613336171998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LIPENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-23
Device Publish Date2022-03-15

On-Brand Devices [Elecsys Syphilis]

07613336171998Syphilis Elecsys E2G 300 V2
07613336171950Syphilis Elecsys cobas e 100 V2
0761333622846309015051162

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