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COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Roche Molecular Systems, Inc.
Trade Name
COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
Generic Name
Cytomegalovirus (cmv) dna quantitative assay
Decision Date
7/5/2012
Days to Decision
255 days
Decision Code
APPR
FDA Decision
Approval

COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Roche Molecular Systems, Inc.
Trade Name
COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
Generic Name
Cytomegalovirus (cmv) dna quantitative assay
Decision Date
7/5/2012
Days to Decision
255 days
Decision Code
APPR
FDA Decision
Approval