Elecsys Anti-HBe, PreciControl Anti-HBe

FDA Premarket Approval P190005 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for use of the elecsys anti-hbe with the cobas e 801 immunoassay analyzer.

DeviceElecsys Anti-HBe, PreciControl Anti-HBe
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantRoche Diagnostics
Date Received2021-04-02
Decision Date2021-11-01
PMAP190005
SupplementS001
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Roche Diagnostics 9115 Hague Road indianapolis, IN 46250

Supplemental Filings

Supplement NumberDateSupplement Type
P190005Original Filing
S001 2021-04-02 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
04015630938872 P190005 000
04015630938865 P190005 000

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