Product code PGI— Microbiology
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
- Classification name
- Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- Device class
- Class 2
- Regulation
- 21 CFR 866.3309
- Advisory panel
- Microbiology
- Total cleared
- 9
- First cleared
- Most recent
FDA classification definition
“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.”
Market context for product code PGI
FDA has cleared devices under product code PGI between 2014 and 2024, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2023
- 2019
- 2018
- 2016
- 2015
- 2014
Top applicants under product code PGI
Recent clearances under product code PGI
- K233349 — Alinity m HSV 1 & 2 / VZV
- K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
- K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
- K180559 — HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
- K173798 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
- K162451 — Solana HSV 1+2/VZV Assay
- K151906 — ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
- K151046 — illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
- DEN140004 — QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.