INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
FDA premarket approval P100027/S011 · decided 2013-10-10
Approval details
- PMA number
- P100027
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INFORM HER-2 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
- 2013-09-12
- Decision date
- 2013-10-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- ADDITION OF A NEW SUPPLIER OF TWO BIOCONJUGATES FOR THE ULTRAVIEW SISH DNP DETECTION KIT AND THE ULTRAVIEW RED ISH DIG DETECTION KIT. BOTH DETECTION KITS ARE PARTS OF THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Roche Digital Pathology Dx (K242783) | Ventana Medical Systems, Inc. | 2024-12-17 |
| VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (DEN240025) | Ventana Medical Systems, Inc. | 2024-12-05 |
| Roche Digital Pathology Dx (VENTANA DP 200) (K232879) | Ventana Medical Systems, Inc. | 2024-06-14 |
| CINtec Histology (K212176) | Ventana Medical Systems, Inc. | 2021-12-10 |
| VENTANA CD30 (Ber-H2) RxDx Assay (K172471) | Ventana Medical Systems, Inc. | 2018-05-08 |
| 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 |