IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP
FDA premarket approval P010007 · decided 2001-11-09
Approval details
- PMA number
- P010007
- Trade name
- IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2001-02-13
- Decision date
- 2001-11-09
- Days to decision
- 269 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- APPROVAL FOR IMMULITE AFP FOR USE WITH THE IMMULITE ANALYZER AND IMMULITE 2000 AFP FOR USE WITH THE IMMULITE 2000 ANALYZER. THESE DEVICES ARE INDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE QUANTITATIVE MEASUREMENT OF ALPHA-FETOPROTEIN (AFP) IN EITHER OF TWO CONTEXTS: A) SERIAL MEASUREMENTS IN HUMAN SERUM TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER: OR B) MEASUREMENT IN MATERNAL SERUM AND AMNIOTIC FLUID DURING GESTATIONAL WEEKS 15 THROUGH 20 - USED IN CONJUNCTION WI
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