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cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System FDA UDI
Generic Name
Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Model / Reference
07000979190 FDA UDI

Identifiers

Catalog Number
07000979190 FDA UDI
Primary DI / UDI-DI
00875197004885 FDA UDI
FDA Product Code
MKT FDA UDI
GMDN Term
Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3174 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Hepatitis B virus 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 Diagnostics Corp.

Sources (1)

  • FDA UDI 98efb26a-312b-41e7-8a82-3266ee79cd1e 33 fields · synced May 30, 2026