510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192376Substantially Equivalent

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack

DiaSorin Molecular LLC, Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192376 is the FDA 510(k) clearance record for Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack, a class II device, cleared for Diasorin Molecular, LLC on under FDA product code PGI (Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples). FDA's definition for product code PGI reads: "For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid". FDA records list 32 510(k) clearances for Diasorin Molecular, LLC, from to . As of , FDA records show one recall naming K192376.

Clearance record

Decision date
Received
(88 days to decision)
Product code
PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Regulation
21 CFR 866.3309
Device class
Class II
Review panel
Microbiology
Applicant
Diasorin Molecular, LLC 11331 Valley View St., Cypress CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PGI

Trailing 12 months

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

FDA records show no clearances under product code PGI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PGI, 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