QUANTIFERON-TB GOLD IN-TUBE
FDA premarket approval P010033/S017 · decided 2011-05-26
Approval details
- PMA number
- P010033
- Supplement
- S017
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- QUANTIFERON-TB GOLD IN-TUBE
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2010-08-30
- Decision date
- 2011-05-26
- Days to decision
- 269 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR REVISIONS TO THE DEVICE PACKAGE INSERT AND MARKETING BOOKLET SUBSEQUENT TO THE PUBLICATION OFTHE CDC'S UPDATED GUIDELINES FOR USING INTERFERON GAMMA RELEASE ASSAYS TO DETECT MYCOBACTERIUM TUBERCULOSIS INFECTION - UNITED STATES, 2010, IN ACCORDANCE WITH THE ORIGINAL PMA POST-APPROVAL REQUIREMENT.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| artus HSV-1/2 QS-RGQ MDx Kit (K142738) | Qiagen | 2014-12-19 |