QUANTIFERON TB GOLD IN TUBE
FDA premarket approval P010033/S011 · decided 2007-10-10
Approval details
- PMA number
- P010033
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- QUANTIFERON TB GOLD IN TUBE
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2006-06-01
- Decision date
- 2007-10-10
- Days to decision
- 496 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR A MODIFICATION OF THE QUANTIFERON - TB GOLD TO AN IN-TUBE COLLECTION SYSTEM THAT CONSISTS OF THREE BLOOD COLLECTION TUBES, NIL, TB ANTIGEN, AND MITOGEN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON - TB GOLD IN-TUBE AND IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST USING A PEPTIDE COCKTAIL SIMULATING ESAT-6, CFP-10 AND TB 7.7(P4) PROTEINS TO STIMULATE CELLS IN HEPARINIZED WHOLE BLOOD DRAWN DIRECTLY INTO SPECIALIZED BLOOD COLLECTION TUBES. DETECTIO
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 |