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Exact Diagnostics HSV2L101

by Exact Diagnostics

Exact Diagnostics HSV2L101 is a Class I device made by Exact Diagnostics, listed in FDA GUDID since 24 Sep 2018 (UDI-DI 00812242030451), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00812242030451 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Exact Diagnostics
Generic name
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
Model / Ref / Catalog
HSV2L101
Primary DI / UDI-DI
00812242030451
FDA product code
OHQ
GMDN term
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control

Other devices from Exact Diagnostics

See all devices from Exact Diagnostics →

Properties

  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)