ARTUS CMV RGQ MDX KIT
FDA premarket approval P130027 · decided 2014-06-02
Approval details
- PMA number
- P130027
- Trade name
- ARTUS CMV RGQ MDX KIT
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Applicant
- Qiagen, Inc.
- Date received
- 2013-12-05
- Decision date
- 2014-06-02
- Days to decision
- 179 days
- Decision code
- APRL
- Product code
- PAB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Hilden
- Statement
- APPROVAL FOR THE ARTUS CMV RGQ MDX KIT. THIS DEVICE IS INDICATED FOR: THE ARTUS CMV RGQ MDX KIT IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HUMAN CYTOMEGALOVIRUS (CMV) DNA IN HUMAN EDTA PLASMA. THE ARTUS CMV RGQ MDX KIT IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF SOLID ORGAN TRANSPLANT PATIENTS WHO ARE UNDERGOING ANTI-CMV THERAPY. THE TEST MEASURES CMV DNA LEVELS IN EDTA PLASMA AND CAN BE USED TO ASSESS CMV VIRAL LOAD RESPONSE TO ANTIVIRAL DRUG THERAPY. THE RESU
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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 |