ARTUS CMV RGQ MDX KIT
FDA premarket approval P130027/S002 · decided 2017-06-02
Approval details
- PMA number
- P130027
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARTUS CMV RGQ MDX KIT
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Applicant
- Qiagen, Inc.
- Date received
- 2016-11-14
- Decision date
- 2017-06-02
- Days to decision
- 200 days
- Decision code
- APPR
- Product code
- PAB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Hilden
- Statement
- Approval to expand the use of the artus CMV RGQ MDx assay system to include the QIAsymphony RGQ MDx system. The new assay system includes the QIAsymphony SP instrument and QIAsymphony DSP Virus/Pathogen Kit for automated sample preparation, automated assay setup on the QIAsymphony AS, artus CMV QS RGQ MDx Kit, and Rotor-Gene Q MDx instrument with Rotor-Gene AssayManager v1.0 software.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ipsogen JAK2 RGQ PCR Kit (K172287) | Qiagen, Inc. | 2018-01-12 |
| ipsogen JAK2 RGQ PCR Kit (DEN160028) | Qiagen, Inc. | 2017-03-27 |