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RealTime 08L21-80

by Abbott Molecular

RealTime 08L21-80 is a Class II device made by Abbott Molecular, approved under FDA PMA P120012 on 20 Jun 2013 and listed in FDA GUDID since 20 Nov 2014 (UDI-DI 00884999036147), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

PMA P120012

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884999036147 UDI-DI Date20 Nov 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPRL from GUDID NumberP120012 Date20 Jun 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P120012 decided 20 Jun 2013 Active
  • FDA GUDID UDI-DI 00884999036147 listed 20 Nov 2014 Listed

Timeline

2 dated events

  1. Approved FDA PMA P120012
  2. Listed FDA GUDID 00884999036147

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
RealTime
Generic name
Hepatitis C virus genotyping IVD, control
Model / Ref / Catalog
08L21-80
Primary DI / UDI-DI
00884999036147
PMA number
FDA product code
OBF
GMDN term
Hepatitis C virus genotyping IVD, control
Device class
Class II
Regulation number
866.3170
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hepatitis C virus genotyping IVD, control

Cleared under the same submission (P120012)

and 1 more cleared under P120012

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)