QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE
FDA premarket approval P010033 · decided 2001-11-28
Approval details
- PMA number
- P010033
- Trade name
- QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2001-06-01
- Decision date
- 2001-11-28
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- Yes
- Location
- Germantown, MD
- Statement
- APPROVAL FOR THE CELLESTIS QUANTIFERON-TB. THE DEVICE IS INDICATED FOR USE AS AN AID IN THE DETECTION OF INFECTION WITH MYCOBACTERIUM TUBERCULOSIS.
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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 |