IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS
FDA premarket approval P010052/S004 · decided 2009-12-16
Approval details
- PMA number
- P010052
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- Date received
- 2008-02-25
- Decision date
- 2009-12-16
- Days to decision
- 660 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Llanberis
- Statement
- APPROVAL FOR IMMULITE/ IMMULITE 1000 ANDIMMULITE 2000 ANTI HBS ASSAY. THE DEVICE IS INDICATED FOR:IMMULITE/ IMMULITE 1000FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE OR IMMULITE 1000 ANALYZERS FOR THEQUALITATIVE AND QUANTITATIVE MEASUREMENT OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN(ANTI-HBS) IN HUMAN SERUM AND PLASMA (HEPARINIZED). ASSAY RESULTS MAY BE USED AS AN AID IN THEDETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV
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|---|---|---|
| IMMULITE® 2000 BR-MA (K233946) | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 |
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