VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

FDA UDI

Class III (US FDA UDI)

by Ventana Medical Systems

Identity

Trade Name: VENTANA FOLR1 (FOLR1-2.1) RxDx Assay FDA UDI
Generic Name: Folate receptor alpha (FRa) IVD, antibody FDA UDI
Model / Reference: 07727917001 FDA UDI

Identifiers

Catalog Number: 07727917001 FDA UDI
Primary DI / UDI-DI: 07613336103241 FDA UDI
PMA Number: P220006 FDA UDI
FDA Product Code: QUL FDA UDI
GMDN Term: Folate receptor alpha (FRa) IVD, antibody FDA UDI

Classification

Device Class: Class III FDA UDI
Regulation Number: 864.1860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Folate receptor alpha (FRa) IVD, antibody

VENTANA FOLR1 (FOLR1-2.1) RxDx Assay by Ventana Medical Systems — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Ventana Medical Systems

Sources (1)

FDA UDI db3020ae-e09b-476e-afa8-3cfcdf64b555 34 fields · synced May 30, 2026