IMMULITE & IMMULITE 2000 HBSAG ASSAY
FDA premarket approval P010050/S007 · decided 2009-02-09
Approval details
- PMA number
- P010050
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMMULITE & IMMULITE 2000 HBSAG ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- Date received
- 2008-12-02
- Decision date
- 2009-02-09
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Llanberis
- Statement
- APPROVAL FOR REPLACEMENT OF THE SODIUM BASED BUFFER WITH POTASSIUM PHOSPHATEBUFFER AND ADDITION OF 2.0% NORMAL MOUSE SERUM AND 1.2% E-AMINO-N-CAPROIC ACID IN REAGENT A,AND THE ADDITION OF 0.2% SODIUM HEPARIN IN REAGENT B FOLLOWED BY REFILTERING OF DILUENT, AND ISINDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE AND CHRONIC HEPATITIS BVIRUS INFECTIONS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION.
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