FDA.reportPublic FDA data

HPV 3 in 1 System Control Slides

Primary DI
04015630971961
Brand
HPV 3 in 1 System Control Slides
Company
Ventana Medical Systems, Inc.
Model
05273587001
Catalog number
05273587001
Published
2021-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KIRCELLS, ANIMAL AND HUMAN, CULTURED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIRCells, Animal And Human, CulturedHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630971961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630971961040156309719614015630971961

GMDN Terms#

Term, Definition table
TermDefinition
C-erbB2/Her2/neu oncoprotein IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184042521
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336236987VENTANA CD15 (MMA.P8) Mouse Monoclonal Antibody10496410001104964100012026-05-18
07613336239063Congo Red Stain Core Kit10585021001105850210012026-04-10
07613336239544Gram Stain Core Kit10608358001106083580012026-04-10
04015630984787SSR Solution06890059001068900590012021-02-03
07613336226568VENTANA® U6 DIG Probe10062746001100627460012026-03-26
07613336240281ASSY RGT DSPNR CARD BMK PREP KIT 30110637412001106374120012026-03-20
07613336240298ASSY RGT DSPNR CARD BMK PREP KIT 30210637439001106374390012026-03-20
07613336240304ASSY RGT DSPNR CARD BMK PREP KIT 30310637447001106374470012026-03-20
07613336240311ASSY RGT DSPNR CARD BMK PREP KIT 30410637455001106374550012026-03-20
07613336240328ASSY RGT DSPNR CARD BMK PREP KIT 30510637463001106374630012026-03-20
07613336240335ASSY RGT DSPNR CARD BMK PREP KIT 30610637471001106374710012026-03-20
07613336240342ASSY RGT DSPNR CARD BMK PREP KIT 30710637480001106374800012026-03-20
07613336240359ASSY RGT DSPNR CARD BMK PREP KIT 30810637498001106374980012026-03-20
07613336240366ASSY RGT DSPNR CARD BMK PREP KIT 30910637501001106375010012026-03-20
07613336240373ASSY RGT DSPNR CARD BMK PREP KIT 31010637536001106375360012026-03-20
07613336240380ASSY RGT DSPNR CARD BMK PREP KIT 31110637544001106375440012026-03-20
07613336240397ASSY RGT DSPNR CARD BMK PREP KIT 31210637552001106375520012026-03-20
07613336240403ASSY RGT DSPNR CARD BMK PREP KIT 31310637579001106375790012026-03-20
07613336240410ASSY RGT DSPNR CARD BMK PREP KIT 31410637587001106375870012026-03-20
07613336240427ASSY RGT DSPNR CARD BMK PREP KIT 31510637595001106375950012026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700575016899PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.KIR2026-04-29
04015630972524HER2 Dual ISH 3-in-1 Xenograft SlidesVentana Medical Systems, Inc.KIR2021-02-03
04015630971091HER2 3-in-1 Xenograft Control SlidesVentana Medical Systems, Inc.KIR2021-01-29
04015630971909HPV FAMILY 6 SYSTEM CONTROL SLIDES [B]Ventana Medical Systems, Inc.KIR2021-01-29
05700573001736PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.KIR2020-11-17
05700571112755PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.KIR2020-11-17
30014613339571Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-10-02
30014613339564Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-09-25
30014613339274Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-07-14
30014613339281Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-07-14
B7829500A07TdT Control Cell SuspensionSupertechs, Inc.KIR2019-10-08
30014613331377Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331384Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331391Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331407Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331414Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331421Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331438Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331445Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331698Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331704Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331711Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331728Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331735Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331742Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331759Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331766Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331773Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331780Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331797Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21