ACCU-CHEK Aviva

GUDID 00365702107106

ACCU-CHEK AVIVA 2 LEVEL CONTROL 6/CS

Roche Diagnostics Operations, Inc.

Glucose IVD, control
Primary Device ID00365702107106
NIH Device Record Key7c8d5bae-e9ea-4f43-a66a-cd5dfcad777f
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCU-CHEK Aviva
Version Model Number04528638001
Company DUNS141608724
Company NameRoche Diagnostics Operations, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100365702107106 [Primary]
GS110365702107103 [Package]
Package: [6 Units]
In Commercial Distribution

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-26

On-Brand Devices [ACCU-CHEK Aviva]

00365702725102ACCU-CHEK AVIVA PLUS METER ONLY US
10365702724102ACCU-CHEK AVIVA PLUS SAMPLE KIT 20/CASE
00365702723108Accu-Chek Aviva Plus Retail Kit 10/case
00365702544109ACCU-CHEK AVIVA MG/DL 455 US
00365702107106ACCU-CHEK AVIVA 2 LEVEL CONTROL 6/CS
00365702702394ACCU-CHEK AVIVA MG/DL 455 US NON-VA

Trademark Results [ACCU-CHEK Aviva]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCU-CHEK AVIVA
ACCU-CHEK AVIVA
78343530 3071846 Live/Registered
Roche Diagnostics GmbH
2003-12-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.