PGH · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3307
Classification
FDA Product Code
PGH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3307
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
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.