Artus CMV RGQ and QS-RGQ MDx Kit
FDA premarket approval P130027/S003 · decided 2017-11-15
Approval details
- PMA number
- P130027
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Artus CMV RGQ and QS-RGQ MDx Kit
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Applicant
- Qiagen, Inc.
- Date received
- 2017-06-29
- Decision date
- 2017-11-15
- Days to decision
- 139 days
- Decision code
- APPR
- Product code
- PAB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Hilden
- Statement
- Approval for a change to the enzyme in a component of the device.
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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 |