VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator

Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)

FDA Premarket Approval P100001 S011

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

Replace the current size exclusion chromatography system with a crossflow tangential flow purification system for the preparation of the biotin conjugate concentrate.

DeviceVITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
Classification NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantORTHO-CLINICAL DIAGNOSTICS
Date Received2017-08-28
Decision Date2017-09-15
PMAP100001
SupplementS011
Product CodeLOM
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ORTHO-CLINICAL DIAGNOSTICS 100 Indigo Creek Dr. rochester, NY 14626-5101

Supplemental Filings

Supplement NumberDateSupplement Type
P100001Original Filing
S017 2022-09-30 Real-time Process
S016 2019-05-21 30-day Notice
S015 2018-10-16 Normal 180 Day Track No User Fee
S014 2018-02-21 Normal 180 Day Track No User Fee
S013 2018-01-25 30-day Notice
S012 2018-01-09 Normal 180 Day Track No User Fee
S011 2017-08-28 30-day Notice
S010 2016-11-17 Normal 180 Day Track
S009 2016-09-12 30-day Notice
S008 2015-08-10 30-day Notice
S007 2015-06-25 30-day Notice
S006 2013-09-20 30-day Notice
S005 2012-11-29 30-day Notice
S004 2012-10-26 30-day Notice
S003 2012-10-17 30-day Notice
S002 2012-09-19 30-day Notice
S001 2012-03-22 30-day Notice

NIH GUDID Devices

Device IDPMASupp
10758750001439 P100001 006
10758750001422 P100001 006

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