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Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

FDA product code PGH · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3307
Review panel
MI
Implant
No
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2025-09-30 – 2025-09-30

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.

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