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cobas&#x00AE PCR Media Uni Swab Sample Kit

FDA UDI

Class I (US FDA UDI)

by Roche Molecular Systems, Inc.

Identity

Trade Name
cobas&#x00AE PCR Media Uni Swab Sample Kit FDA UDI
Generic Name
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Model / Reference
07958030190 FDA UDI

Identifiers

Catalog Number
07958030190 FDA UDI
Primary DI / UDI-DI
00875197005721 FDA UDI
FDA Product Code
MKZ FDA UDI
LIO FDA UDI
OOI FDA UDI
LSL FDA UDI
GMDN Term
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

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

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

cobas&#x00AE PCR Media Uni Swab Sample Kit by Roche Molecular Systems, Inc. — Class I — 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 b3ac57e2-fde9-4578-ba93-e0b91a300217 33 fields · synced Jun 9, 2026