• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceIMMULITE 2000 HBS AG CONFIRMATORY KIT
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)
Applicant
Siemens Healthcare Diagnostics Products, LTD
glyn rhonwy
llanberis, caernarfon LL55
PMA NumberP010050
Supplement NumberS011
Date Received09/29/2010
Decision Date06/24/2011
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN AUTOMATED MEANS OF CONFIRMATION TESTING ON-BOARD THE IMMULITE 2000 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2000 HBSAG CONFIRMATORY KIT AND IS INDICATED FOR: IMMULITE 2000 HBSAG CONFIRMATORY IS INTENDED FOR IN VITRO DIAGNOSTIC USE WITH IMMULITE 2000 ANALYZERS IN CONJUNCTION WITH THE IMMULITE 2000 HBSAG ASSAY - FOR THE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (EDTA, HEPARINIZED, CITRATE) THAT WERE REPEATEDLY REACTIVE WHEN TESTED BY THE IMMULITE/ IMMULITE 1000 HBSAG ASSAY OR BY THE IMMULITE 2000 HBSAG ASSAY.
-
-