QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE
FDA premarket approval P010033/S028 · decided 2016-04-27
Approval details
- PMA number
- P010033
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2016-03-25
- Decision date
- 2016-04-27
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Addition of a component manufacturing site.
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 |
|---|---|---|
| artus HSV-1/2 QS-RGQ MDx Kit (K142738) | Qiagen | 2014-12-19 |