ASSY, Reag.Disp.Card, BMK Prep Kit 523

FDA UDI

Class I (US FDA UDI)

by Ventana Medical Systems

Identity

Trade Name: ASSY,Reag.Disp.Card, BMK Prep Kit 523 FDA UDI
Generic Name: Assay container IVD, single-use FDA UDI
Model / Reference: 05254485001 FDA UDI

Identifiers

Catalog Number: 05254485001 FDA UDI
Primary DI / UDI-DI: 07613336126400 FDA UDI
FDA Product Code: JRC FDA UDI
GMDN Term: Assay container IVD, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2050 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Assay container IVD, single-use

ASSY, Reag.Disp.Card, BMK Prep Kit 523 by Ventana Medical Systems — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Ventana Medical Systems

Sources (1)

FDA UDI 613e29b1-8a9e-4c3e-9ba5-f8c8ced3b897 33 fields · synced May 30, 2026