IMMULITE 2000 XPI HBSAG
FDA premarket approval P010050 · decided 2002-07-26
Approval details
- PMA number
- P010050
- Trade name
- IMMULITE 2000 XPI HBSAG
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- Date received
- 2001-08-31
- Decision date
- 2002-07-26
- Days to decision
- 329 days
- Decision code
- APRL
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Llanberis
- Statement
- APPROVAL FOR THE IMMULITE HBSAG, IMMULITE 2000 HBSAG AND IMMULITE HBSAG CONFIRMATORY KIT. THESE DEVICES ARE INDICATED FOR: IMMULITE HBSAG: IMMULITE HBSAG IS A SOLID-PHASED CHEMILUMINESCENT ENZYME IMMUNOASSAY DESIGNED FOR IN VITRO USE WITH THE IMMULITE AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (EDTA, HEPARINIZED, CITRATE). IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE AND CHRONIC
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IMMULITE® 2000 BR-MA (K233946) | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 |
| IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA (K213510) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-09-08 |
| IMMULITE® 2000 Cortisol (K202826) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 |
| IMMULITE/IMMULITE® 1000 Cortisol (K203270) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 |