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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hsv-1 and hsv-2 cns nucleic-acid based panel
Definition Intended for the qualitative detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of Herpes Simplex Virus (HSV) central nervous system (CNS) infection. This test is an aid in the diagnosis of HSV-1 and HSV-2 CNS infections in conjunction with other clinical and laboratory findings. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
Product CodePGH
Regulation Number 866.3307
Device Class 2

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