HER2 FISH PHARMDX KIT
FDA premarket approval P040005/S002 · decided 2008-02-13
Approval details
- PMA number
- P040005
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HER2 FISH PHARMDX KIT
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2007-10-29
- Decision date
- 2008-02-13
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL FOR MODIFICATION OF THE CEN 17 REFERENCE PNA PROBES IN VIAL 3 PROBE MIX, ADJUSTMENT OF THE HER2 GENE TARGETED DNA PROBE CONCENTRATIONS IN VIAL 3 PROBE MIX, CHANGE IN AUXILIARY MATERIALS IN TEXAS RED NICK TRANSLATION AND USE OF SEPHADEX G-50 COLUMNS FOR PURIFICATION OF NICK TRANSLATION PRODUCTS.
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