cobas® NHP Negative Control Kit

FDA UDI

Class II (US FDA UDI)

by Roche Molecular Systems, Inc.

Identity

Trade Name: cobas® NHP Negative Control Kit FDA UDI
Generic Name: PCR/NAT negative control IVD FDA UDI
Model / Reference: 09051554190 FDA UDI

Identifiers

Catalog Number: 09051554190 FDA UDI
Primary DI / UDI-DI: 00875197006445 FDA UDI
FDA Product Code: MZF FDA UDI
GMDN Term: PCR/NAT negative control IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3956 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: PCR/NAT negative control IVD

cobas® NHP Negative Control Kit by Roche Molecular Systems, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Roche Molecular Systems, Inc.

Sources (1)

FDA UDI f73e5df3-0fe1-4e08-adc8-6da1b0abc7b9 33 fields · synced Jun 9, 2026