AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST
FDA premarket approval P940040/S003 · decided 2004-04-22
Approval details
- PMA number
- P940040
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2004-04-07
- Decision date
- 2004-04-22
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- MWA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- CHANGE TO THE MANUFACTURING PROCESS OF THE DEVICE TO INCORPORATE A TERMINAL 0.2UM FILTRATION STEP TO THE AVIDIN-HORSERADISH PEROXIDASE (HRP) BGG CONJUGATE REAGENT MANUFACTURING PROCESS TO ENSURE THE REMOVAL OF ADVENTITIOUS AGENTS REMAINING IN THE REAGENT FOLLOWING FORMULATION.
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510(k) clearances by this applicant
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|---|---|---|
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