cobas omni Utility Channel Reagent Kit

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name: cobas omni Utility Channel Reagent Kit FDA UDI
Generic Name: Nucleic acid amplification mastermix kit IVD FDA UDI
Model / Reference: 07557272190 FDA UDI

Identifiers

Catalog Number: 07557272190 FDA UDI
Primary DI / UDI-DI: 00875197005561 FDA UDI
FDA Product Code: NSU FDA UDI
GMDN Term: Nucleic acid amplification mastermix kit IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.2570 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Nucleic acid amplification mastermix kit IVD

cobas omni Utility Channel Reagent Kit by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid amplification mastermix kit IVD.

MGB Alert PCR Master Mix 09N41-004 — ELITechGroup MDX LLC. · Class I
MGB Alert 2X PCR Master Mix 48 rxn — ELITechGroup MDX LLC. · Class I
D CAL 1 Kit — EXACT SCIENCES CORPORATION · Class III
CAR SLN Kit — EXACT SCIENCES CORPORATION · Class III
MGB Alert Platinum Master Mix with water-480rxn — ELITechGroup MDX LLC. · Class I
QIAcuityDx® Universal MasterMix Kit — Qiagen, Inc. · Class I
Spartan RX CYP2C19 System — Spartan Bioscience, Inc. · Class II
D CAL 2 Kit — EXACT SCIENCES CORPORATION · Class III

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Roche Diagnostics Corp.

Sources (1)

FDA UDI f12506b9-8614-4373-9695-90cb79de3428 33 fields · synced May 30, 2026