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VENTANA HER2 Dual ISH DNA Probe Cocktail

FDA UDI

Class III (US FDA UDI)

by Ventana Medical Systems

Identity

Trade Name
VENTANA HER2 Dual ISH DNA Probe Cocktail FDA UDI
Generic Name
Nucleic acid hybridization detection IVD, probe FDA UDI
Model / Reference
08314365001 FDA UDI

Identifiers

Catalog Number
08314365001 FDA UDI
Primary DI / UDI-DI
07613336158432 FDA UDI
PMA Number
P190031 FDA UDI
FDA Product Code
NYQ FDA UDI
GMDN Term
Nucleic acid hybridization detection IVD, probe FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Nucleic acid hybridization detection IVD, probe

VENTANA HER2 Dual ISH DNA Probe Cocktail by Ventana Medical Systems — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid hybridization detection IVD, probe.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ventana Medical Systems

Sources (1)

  • FDA UDI 877db5c3-c2a6-483b-8fbd-4af78b3f1e78 34 fields · synced Jun 8, 2026