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Exact Diagnostics 12020068

by Exact Diagnostics

Exact Diagnostics 12020068 is a Class I device made by Exact Diagnostics, listed in FDA GUDID since 27 Aug 2024 (UDI-DI 03610522384372), 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 Number03610522384372 UDI-DI Date27 Aug 2024ListedStatusListed 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  • Withdrawn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
PCR/NAT negative control IVD
Model / Ref / Catalog
12020068
Primary DI / UDI-DI
03610522384372
FDA product code
OHQ
GMDN term
PCR/NAT negative control IVD
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: PCR/NAT negative control IVD

Similar devices

Other devices filed under FDA product code OHQ (Multi-Analyte Controls Unassayed).

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)