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Elecsys HBsAg II

FDA UDI

Class U (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Elecsys HBsAg II FDA UDI
Generic Name
Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
08814848162 FDA UDI

Identifiers

Catalog Number
08814848162 FDA UDI
Primary DI / UDI-DI
07613336183076 FDA UDI
FDA Product Code
QHM FDA UDI
GMDN Term
Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
610.40 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Elecsys HBsAg II by Roche Diagnostics Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay.

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 432ec56d-4cea-4a72-b8df-d82305b0e87e 33 fields · synced May 31, 2026