FDA-Device2013-05-22Class II

QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.

QIAGEN Gaithersburg, Inc.
Hazard

CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.

Sold states
USA Nationwide Distribution including the states of: CA, DC, FL, GA, MA, MD, MI, and IL.
Affected count
90 kits in total
Manufactured in
1201 Clopper Rd, Gaithersburg, MD, United States
Products
QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1320-2013

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