PMA P040005S002
- Device
- HER2 FISH PHARMDX KIT
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S002
- Product code
- MVD
- Decision date
- 2008-02-13
- Classification
- System, Test, Her-2/neu, Nucleic Acid Or Serum
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Approval order 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.
Current openFDA PMA Record#
- Device
- HER2 FISH PHARMDX KIT
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S002
- Product code
- MVD
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Decision date
- 2008-02-13
- Decision code
- APPR
- Date received
- 2007-10-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.