artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit
FDA premarket approval P130027/S006 · decided 2018-09-26
Approval details
- PMA number
- P130027
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Applicant
- Qiagen, Inc.
- Date received
- 2018-08-30
- Decision date
- 2018-09-26
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- PAB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Hilden
- Statement
- Modify the bulk manufacturing process and QC testing for an assay control reagent.
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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 |