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Exact Diagnostics HCVP100

by Exact Diagnostics

Exact Diagnostics HCVP100 is a hepatitis C virus nucleic acid IVD (FDA Class II; FDA product code JIT, Calibrator, Secondary) made by Exact Diagnostics, listed in FDA GUDID since 24 Sep 2018 (UDI-DI 00812242030086), 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 Number00812242030086 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  • Withdrawn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
Hepatitis C virus nucleic acid IVD, calibrator
Model / Ref / Catalog
HCVP100
Primary DI / UDI-DI
00812242030086
FDA product code
JIT
GMDN term
Hepatitis C virus nucleic acid IVD, calibrator
Device class
Class II
Regulation number
862.1150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hepatitis C virus nucleic acid IVD, calibrator

Similar devices

Other devices filed under FDA product code JIT (Calibrator, Secondary).

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)