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Elecsys HBsAg Test System

by Roche Diagnostics Corp.

PMA P990012

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 1 Jun 2001

PMA

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP990012 Date1 Jun 2001Approval withdrawnStatusWithdrawn

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Trade Name
Elecsys Hbsag Immunoassay, Elecsys Hbsag Confirmatory, and Precicontrol Hbsag
Generic Name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
PMA Number
FDA Product Code
LOM
Device Class
Class II
Regulation
21 CFR Part 866.3172
Advisory Committee
Microbiology
FDA Decision
APWD Approval withdrawn

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