IMMULITE AFP AND IMMULITE 2000 AFP
FDA premarket approval P010007/S001 · decided 2003-02-24
Approval details
- PMA number
- P010007
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMMULITE AFP AND IMMULITE 2000 AFP
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2003-01-21
- Decision date
- 2003-02-24
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- APPROVAL FOR USE OF THE IMMULITE AFP ON THE IMMULITE 1000 AUTOMATED ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE/IMMULITE 1000 AFP AND IS INDICATED: FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE AND IMMULTE 1000 ANALYZERS - 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) MEASUREMENTS IN MATERNAL SERU
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