INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
FDA premarket approval P100027/S018 · decided 2014-07-30
Approval details
- PMA number
- P100027
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2014-05-01
- Decision date
- 2014-07-30
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR THE EXTENSION OF STABILITY DATING FOR THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL SYSTEM, WHICH INCLUDES THE FOLLOWING PRODUCTS: INFORM HER2 DUAL ISH DNA PROBE COCKTAIL, ULTRAVIEW RED ISH DIG DETECTION KIT, ULTRAVIEW SISH DNP DETECTION KIT.
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510(k) clearances by this applicant
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|---|---|---|
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| CINtec Histology (50 tests), CINtec Histology (250 tests) (DEN160019) | Ventana Medical Systems, Inc. | 2017-03-04 |
| Virtuoso System for IHC PR (1E2) using iScan HT (K142965) | Ventana Medical Systems, Inc. | 2015-07-16 |
| VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (K140465) | Ventana Medical Systems, Inc. | 2014-03-20 |