FDA-Device2013-09-04Class II

HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.

Life Technologies Corporation
Hazard

Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.

Sold states
USA Nationwide Distribution in the states of DE, IA, MN, and NC.
Affected count
15 kits
Manufactured in
7335 Executive Way, Frederick, MD, United States
Products
HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2085-2013

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