FDA.reportPublic FDA data

ACCU-CHEK AVIVA EXPERT

Primary DI
00365702595101
Brand
ACCU-CHEK AVIVA EXPERT
Company
Roche Diagnostics Operations, Inc.
Model
07189494001
Catalog number
07189494001
Device description
ACCU-CHEK AVIVA EXPERT DEMO KIT
Published
2016-08-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LFRGlucose Dehydrogenase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00365702595101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00365702595101003657025951013657025951010365702595101

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
141608724
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00365702703216ACCU-CHEK GUIDE10439050001 10439050001 2025-03-20
00365702703230ACCU-CHEK GUIDE10439165001 10439165001 2025-03-20
00365702703254ACCU-CHECK GUIDE10439238001 10439238001 2025-03-20
00365702703209 ACCU-CHEK GUIDE10436271001 10436271001 2025-03-20
10365702703213ACCU-CHEK GUIDE10439050001 10439050001 2025-03-20
10365702703237ACCU-CHEK GUIDE10439165001 10439165001 2025-03-20
10365702703251ACCU-CHECK GUIDE10439238001 10439238001 2025-03-20
00365702731103Accu-Chek Guide Me084998960012019-04-08
00365702729100Accu-Chek Guide084530710012018-03-02
00365702702882ACCU-CHEK GUIDE LINK09978330001099783300012023-09-21
00365702702417ACCU-CHEK GUIDE LINK08109257002081092570022023-09-21
10365702702889ACCU-CHEK GUIDE LINK09978330001099783300012023-09-21
00365702702479ACCU-CHEK GUIDE LINK09651926001096519260012023-09-06
00365702702530ACCU-CHEK GUIDE LINK09651942001 09651942001 2023-09-06
10365702702476ACCU-CHEK GUIDE LINK09651926001096519260012023-09-06
10365702702537ACCU-CHEK GUIDE LINK09651942001 09651942001 2023-09-06
00365702724105Accu-Chek Aviva 083500600012018-03-01
00365702702394Accu-Chek Aviva083403310012019-02-28
00365702134102ACCU-CHEK AVIVA PLUS 07021941001070219410012016-08-26
00365702405103ACCU-CHEK AVIVA PLUS06908152001069081520012016-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00301939628021CONTOUR® NEXT EZASCENSIA DIABETES CARE US INC.LFR2025-01-06
00353885012836OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2024-01-31
00353885012799OneTouch Verio FlexLifeScan Europe GmbHLFR2023-05-26
40301939660517CONTOUR® NEXT EZ, CONTOUR® NEXT GEN and CONTOUR® NEXTASCENSIA DIABETES CARE US INC.LFR2022-11-23
00353885012102OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2022-08-31
00353885012621OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2022-08-31
00353885012638OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012645OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012683OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012485OneTouch Verio FlexLifeScan Europe GmbHLFR2022-05-19
00301937828010CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2022-01-07
00301939550018CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2021-12-08
00301937825019CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2021-11-22
00353885012423OneTouch VerioLifeScan Europe GmbHLFR2021-09-18
00021292014797TRUE METRIXTRIVIDIA HEALTH, INC.LFR2021-08-06
00301937553011CONTOUR® NEXT EZASCENSIA DIABETES CARE US INC.LFR2021-07-30
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
10612479250441MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
10612479250458MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
00353885012188OneTouch VerioLifeScan Europe GmbHLFR2020-06-30
50096295139551TRUE METRIXTRIVIDIA HEALTH, INC.LFR2020-05-11
00357599807009FreeStyle Precision ProABBOTT DIABETES CARE INCLFR2020-04-15
00357599808006FreeStyle Precision ProABBOTT DIABETES CARE INCLFR2020-04-15
00353885012034OneTouch VerioLifeScan Europe GmbHLFR2020-04-12
10096295139553TRUE METRIXTRIVIDIA HEALTH, INC.LFR2020-04-10
10021292014299TRUE METRIXTRIVIDIA HEALTH, INC.LFR2020-03-18
10021292014305TRUE METRIXTRIVIDIA HEALTH, INC.LFR2020-03-18