IMMULITE 2000 XPI ANTI-HBC IMG
FDA premarket approval P010053 · decided 2002-07-26
Approval details
- PMA number
- P010053
- Trade name
- IMMULITE 2000 XPI ANTI-HBC IMG
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- 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
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Llanberis
- Statement
- APPROVAL FOR THE IMMULITE ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBC IGM. THESE DEVICES ARE INDICATED FOR: IMMULITE. ANTI-HBC IGM: IMMULITE ANTI-HBC IGM IS A SOLID-PHASE CHEMILUMINESCENT ENZYME IMMUNOASSAY DESIGNED FOR USE WITH THE IMMULITE AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE MEASUREMENT OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM AND PLASMA (EDTA, HEPARINIZED OR CITRATE). IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE O
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510(k) clearances by this applicant
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|---|---|---|
| IMMULITE® 2000 BR-MA (K233946) | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 |
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| IMMULITE® 2000 Cortisol (K202826) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 |
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