Elecsys HIV Duo 08836973190

GUDID 07613336166949

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 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 ID07613336166949
NIH Device Record Key44fec284-db89-4922-99a9-78fc07053ea6
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys HIV Duo
Version Model Number08836973190
Catalog Number08836973190
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336166949 [Primary]
GS107613336166949 [Primary]
GS107613336166949 [Primary]
GS107613336166949 [Primary]
GS107613336166949 [Primary]
GS107613336166949 [Primary]
GS107613336166949 [Primary]
GS107613336166949 [Primary]
GS107613336166949 [Primary]
GS107613336166949 [Primary]
GS107613336166949 [Primary]
GS107613336166949 [Primary]
GS107613336166949 [Primary]
GS107613336166949 [Primary]
GS107613336166949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MZFTest, HIV detection
MZFTest, HIV detection
MZFTest, HIV detection
MZFTest, HIV detection
MZFTest, HIV detection
MZFTest, HIV detection
MZFTest, HIV detection
MZFTest, HIV detection
MZFTest, HIV detection
MZFTest, HIV detection
MZFTest, HIV detection
MZFTest, HIV detection
MZFTest, HIV detection
MZFTest, HIV detection
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 Date2020-06-23
Device Publish Date2020-06-15

Devices Manufactured by Roche Diagnostics GmbH

07613336166949 - Elecsys HIV Duo2020-06-23
07613336166949 - Elecsys HIV Duo2020-06-23
04015630913060 - Elecsys Insulin2020-05-22
04015630921546 - Elecsys Prolactin II2020-05-22
04015630946839 - Tina-quant CReactive Protein IV2020-05-21
04015630946846 - Tina-quant CReactive Protein IV2020-05-21
04015630946853 - Tina-quant CReactive Protein IV2020-05-21
04015630946594 - Elecsys PCT CalCheck 52020-05-12
07613336166635 - Elecsys BRAHMS PCT2020-05-08

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