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Elecsys HBsAg Immunoassay

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Elecsys HBsAg Immunoassay FDA UDI
Generic Name
Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
11820532160 FDA UDI

Identifiers

Catalog Number
11820532160 FDA UDI
Primary DI / UDI-DI
04015630911073 FDA UDI
PMA Number
P990012 FDA UDI
FDA Product Code
LOM FDA UDI
GMDN Term
Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3172 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Elecsys HBsAg Immunoassay by Roche Diagnostics Corp. — Class II — 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 b28baf1e-cf7c-4a08-ac2a-e4e5824b0692 35 fields · synced Jun 8, 2026