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cobas PCR Media Dual Swab Sample Kit

FDA UDI

Class II (US FDA UDI)

by Roche Molecular Systems, Inc.

Identity

Trade Name
cobas PCR Media Dual Swab Sample Kit FDA UDI
Generic Name
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Model / Reference
07958021190 FDA UDI

Identifiers

Catalog Number
07958021190 FDA UDI
Primary DI / UDI-DI
00875197005738 FDA UDI
FDA Product Code
LSL FDA UDI
OOI FDA UDI
MKZ FDA UDI
LIO FDA UDI
GMDN Term
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3390 FDA UDI
862.2570 FDA UDI
866.3120 FDA UDI
866.2900 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

Yes

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
MRI Safety
MR Safe FDA UDI

Category: Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas PCR Media Dual Swab Sample Kit by Roche Molecular Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type sexually transmitted pathogen 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 dad26b9d-9a88-40c2-9a93-3fd4695ff15b 33 fields · synced Jun 9, 2026