510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PGHClass II

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

21 CFR 866.3307 / Microbiology
FDA source (opens on fda.gov)

PGH is the FDA product code for Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel, a class II device type, regulated under 21 CFR 866.3307. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PGH
Device name
Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
FDA 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.
Regulation
21 CFR 866.3307
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
1

Clearances, product code PGH

By decision year
3 clearances under product code PGH with a decision year between 2014 and 2025, 2014 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PGH by decision year
YearClearances
20142
20251

Applicants with the most clearances

Product code PGH
Applicants holding the most 510(k) clearances under product code PGH
ApplicantClearances
DiaSorin Molecular LLC2
Midiagnostics NV1

Companies listing this code with FDA

Companies whose registered establishments list this code