Elecsys HIV combi PT 08924163160

GUDID 07613336170182

Roche Diagnostics GmbH

HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Primary Device ID07613336170182
NIH Device Record Keyba67ad4f-239f-4d78-a45b-363f1a37240c
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys HIV combi PT
Version Model Number08924163160
Catalog Number08924163160
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
GS107613336170182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MZFTest, HIV detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-24
Device Publish Date2021-09-16

On-Brand Devices [Elecsys HIV combi PT]

0761333617021208924180160
0761333617018208924163160
04015630942497HIV combi PT Elecsys cobas e 100

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