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VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail

FDA UDI

Class II (US FDA UDI)

by Ventana Medical Systems

Identity

Trade Name
VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail FDA UDI
Generic Name
Kappa/lambda light chain messenger RNA IVD, probe FDA UDI
Model / Reference
08507015001 FDA UDI

Identifiers

Catalog Number
08507015001 FDA UDI
Primary DI / UDI-DI
07613336160541 FDA UDI
510(k) Number
DEN240025 FDA UDI
FDA Product Code
SDP FDA UDI
GMDN Term
Kappa/lambda light chain messenger RNA IVD, probe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.1861 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

No

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: Kappa/lambda light chain messenger RNA IVD, probe

VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail by Ventana Medical Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Kappa/lambda light chain messenger RNA 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 3b3141ce-ed35-4ba9-a5a4-97ef80123372 34 fields · synced Jun 8, 2026