Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | HER2 FISH PHARMDX KIT |
Generic Name | SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM |
Applicant | Agilent Technologies Singapore (International) Pte Ltd. No. 1 Yishun Avenue 7 Singapore 76892 |
PMA Number | P040005 |
Supplement Number | S002 |
Date Received | 10/29/2007 |
Decision Date | 02/13/2008 |
Product Code |
MVD |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
|
|