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cobas HPV

FDA UDI

Class III (US FDA UDI)

by Roche Molecular Systems, Inc.

Identity

Trade Name
cobas HPV FDA UDI
Generic Name
Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Model / Reference
09040544190 FDA UDI

Identifiers

Catalog Number
09040544190 FDA UDI
Primary DI / UDI-DI
00875197006889 FDA UDI
FDA Product Code
MAQ FDA UDI
GMDN Term
Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) 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: Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas HPV by Roche Molecular Systems, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT).

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 fee55e93-872a-47f3-ab0f-3c6f52ba9f0d 33 fields · synced Jun 9, 2026