ARTUS CMV RGQ MDX KIT
FDA premarket approval P130027/S001 · decided 2015-07-09
Approval details
- PMA number
- P130027
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARTUS CMV RGQ MDX KIT
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Applicant
- Qiagen, Inc.
- Date received
- 2015-06-12
- Decision date
- 2015-07-09
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- PAB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Hilden
- Statement
- CHANGE TO THE SUPPLIER OF THE POSITIVE MATERIALS USED IN THE ARTUS CMV RGQ MDX KIT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |