QUANTIFERON-TB GOLD AND TB GOLD Test (reference lab pack)
FDA premarket approval P010033/S029 · decided 2016-08-19
Approval details
- PMA number
- P010033
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- QUANTIFERON-TB GOLD AND TB GOLD Test (reference lab pack)
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2016-07-21
- Decision date
- 2016-08-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Addition of two alternate suppliers for a raw material used to produce a critical assay component.
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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 |