510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130049Unknown

Simplexa Hsv 1&2 Direct

DiaSorin Molecular LLC, Cypress CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN130049 is the FDA 510(k) clearance record for SIMPLEXA HSV 1&2 DIRECT, a class II device, cleared for Focus Diagnostics on under FDA product code PGH (Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel). FDA's definition for product code PGH 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...". FDA records list 32 510(k) clearances for DiaSorin Molecular LLC, from to . As of , FDA records show no recalls naming DEN130049.

Clearance record

Decision date
Received
(116 days to decision)
Product code
PGH Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
Regulation
21 CFR 866.3307
Device class
Class II
Review panel
Microbiology
Applicant
Focus Diagnostics 11331 Valley View St., Cypress CA
Third party review
No

Clearances, product code PGH

Trailing 12 months

FDA records hold no clearances under product code PGH in the trailing twelve months.

FDA records show no clearances under product code PGH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PGH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260