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cobas&#x00AE EBV/BKV Control Kit

FDA UDI

Class II (US FDA UDI)

by Roche Molecular Systems, Inc.

Identity

Trade Name
cobas&#x00AE EBV/BKV Control Kit FDA UDI
Generic Name
Multiple immunocompromised host infection-associated virus nucleic acid IVD, control FDA UDI
Model / Reference
08688214190 FDA UDI

Identifiers

Catalog Number
08688214190 FDA UDI
Primary DI / UDI-DI
00875197006254 FDA UDI
FDA Product Code
QLX FDA UDI
GMDN Term
Multiple immunocompromised host infection-associated virus nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3183 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Multiple immunocompromised host infection-associated virus nucleic acid IVD, control

cobas&#x00AE EBV/BKV Control Kit by Roche Molecular Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Molecular Systems, Inc.

Sources (1)

  • FDA UDI a466e4f7-f927-4a03-b941-64748d2b07d9 33 fields · synced Jun 9, 2026