FDA.reportPublic FDA data

VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

Primary DI
07613336103241
Brand
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
Company
Ventana Medical Systems, Inc.
Model
07727917001
Catalog number
07727917001
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QULImmunohistochemistry Assay, Antibody, FOLR1

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QULImmunohistochemistry Assay, Antibody, Folr1Hematology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220006000
P220006001
P220006005
P220006006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220006000VENTANA FOLR1 (FOLR-2.1) RxDx AssayVentana Medical Systems, Inc.2022-11-14QUL
P220006001VENTANA FOLR1 (FOLR-2.1) RxDx AssayVentana Medical Systems, Inc.2022-11-14QUL
P220006005VENTANA FOLR1 (FOLR-2.1) RxDx AssayVentana Medical Systems, Inc.2022-11-14QUL
P220006006VENTANA FOLR1 (FOLR-2.1) RxDx AssayVentana Medical Systems, Inc.2022-11-14QUL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336103241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336103241076133361032417613336103241

GMDN Terms#

Term, Definition table
TermDefinition
Folate receptor alpha (FRa) IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of folate receptor alpha (FRa), in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336239025VENTANA MTAP (SP530) Rabbit Monoclonal Antibody10574518001105745180012026-06-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336188019VENTANA FOLR1 Stain Intensity Reference SlideVentana Medical Systems, Inc.QUL2022-12-01