QUANTIFERON-TB
FDA premarket approval P010033/S003 · decided 2003-03-17
Approval details
- PMA number
- P010033
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- QUANTIFERON-TB
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2003-02-20
- Decision date
- 2003-03-17
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE THAT ENHANCE THE SAFE USE OF THE QUANTIFERON-TB BY INCORPORATING RECOMMENDATIONS FROM THE "CDC GUIDELINES FOR USING THE QUANTIFERON-TB TEST FOR DIAGNOSING LATENT MYCOBACTERIUM TUBERCULOSIS INFECTION" (MMWR DISPATCH, VOL. 51/DECEMBER 18, 2002).
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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 |