QUANTIFERON -TB GOLD
FDA premarket approval P010033/S006 · decided 2004-12-02
Approval details
- PMA number
- P010033
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- QUANTIFERON -TB GOLD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2003-12-04
- Decision date
- 2004-12-02
- Days to decision
- 364 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR THE USE OF SYNTHETIC PEPTIDE ANTIGENS ESAT-6 AND CFP-10 AND REMOVAL OF THE TUBERCULIN PPD AND M. AVIUM PPD ANTIGENS USED IN THE QUANTIFERON - TB. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON - TB GOLD AND IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST USING PEPTIDE COCKTAILS SIMULATING ESAT-6 AND CFP-10 PROTEINS TO STIMULATE CELLS IN HEPARINIZED WHOLE BLOOD. DETECTION OF INTERFERON-Y BY ELISA IS USED TO IDENTIFY IN VITRO RESPONSES TO ESAT-6 AND CFP
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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 |