Skip to content

Exact Diagnostics COV019CE

by Exact Diagnostics

Exact Diagnostics COV019CE is a Class I device made by Exact Diagnostics, listed in FDA GUDID since 17 Jun 2022 (UDI-DI 00812242030888), 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 Number00812242030888 UDI-DI Date17 Jun 2022ListedStatusListed 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  • Withdrawn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
SARS-CoV-2 nucleic acid IVD, control
Model / Ref / Catalog
COV019CE
Primary DI / UDI-DI
00812242030888
FDA product code
OHQ
GMDN term
SARS-CoV-2 nucleic acid IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: SARS-CoV-2 nucleic acid IVD, control

Similar devices in this category

Other devices filed under SARS-CoV-2 nucleic acid IVD, control.

Other devices from Exact Diagnostics

See all devices from Exact Diagnostics →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)