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cobas liat SARS-CoV-2, Influenza A/B & RSV control kit

FDA UDI

Class II (US FDA UDI)

by Roche Molecular Systems, Inc.

Identity

Trade Name
cobas liat SARS-CoV-2, Influenza A/B & RSV control kit FDA UDI
Generic Name
Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI
Model / Reference
09731270190 FDA UDI

Identifiers

Catalog Number
09731270190 FDA UDI
Primary DI / UDI-DI
00875197007305 FDA UDI
510(k) Number
K243406 FDA UDI
FDA Product Code
QOF FDA UDI
GMDN Term
Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3981 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple-genus respiratory virus nucleic acid IVD, control

cobas liat SARS-CoV-2, Influenza A/B & RSV control kit by Roche Molecular Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Multiple-genus respiratory virus nucleic acid IVD, control.

Cleared under the same submission

K243406 also covers:

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 df6f95cb-d4cd-4de2-8524-25a82c74ecf1 34 fields · synced Jun 9, 2026