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RealTime 1N30-80

by Abbott Molecular

RealTime 1N30-80 is a Class II device made by Abbott Molecular, listed in FDA GUDID since 20 Nov 2014 (UDI-DI 00884999000711), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884999000711 UDI-DI Date20 Nov 2014ListedStatusListed 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  • Withdrawn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
RealTime
Generic name
Hepatitis C virus nucleic acid IVD, control
Model / Ref / Catalog
1N30-80
Primary DI / UDI-DI
00884999000711
FDA product code
MZP
GMDN term
Hepatitis C virus nucleic acid IVD, control
Device class
Class II
Regulation number
866.3170
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hepatitis C virus nucleic acid IVD, control

Similar devices

Other devices filed under FDA product code MZP (ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS).

Other devices from Abbott Molecular

See all devices from Abbott Molecular →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)