Implementation of an incoming specification for zinc content for 2-amino-2-methyl-1- propanol (amp) buffer and elimination of substrate verification testing.
| Device | IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & 2000 HBSAG CONFIRMATORY |
| Classification Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Siemens Healthcare Diagnostics Products, LTD |
| Date Received | 2011-08-16 |
| Decision Date | 2011-09-13 |
| PMA | P010050 |
| Supplement | S014 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Siemens Healthcare Diagnostics Products, LTD glyn Rhonwy llanberis, Caernarfon LL55 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010050 | | Original Filing |
| S021 |
2022-09-15 |
30-day Notice |
| S020 | | |
| S019 |
2021-05-12 |
30-day Notice |
| S018 |
2020-08-12 |
30-day Notice |
| S017 |
2019-11-25 |
30-day Notice |
| S016 |
2014-07-02 |
135 Review Track For 30-day Notice |
| S015 |
2011-12-19 |
135 Review Track For 30-day Notice |
| S014 |
2011-08-16 |
30-day Notice |
| S013 |
2011-08-08 |
30-day Notice |
| S012 |
2011-02-18 |
Real-time Process |
| S011 |
2010-09-29 |
Normal 180 Day Track |
| S010 |
2009-11-02 |
Normal 180 Day Track No User Fee |
| S009 | | |
| S008 |
2009-05-13 |
Real-time Process |
| S007 |
2008-12-02 |
Normal 180 Day Track |
| S006 |
2008-11-10 |
Normal 180 Day Track No User Fee |
| S005 |
2006-08-04 |
30-day Notice |
| S004 | | |
| S003 |
2003-05-22 |
30-day Notice |
| S002 | | |
| S001 |
2002-11-20 |
Real-time Process |
NIH GUDID Devices