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RealTime 6L18-80

by Abbott Molecular

RealTime 6L18-80 is a Class II device made by Abbott Molecular, listed under FDA premarket submission BP060002 and listed in FDA GUDID since 1 Jul 2016 (UDI-DI 00884999023932), 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 BP060002

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 Number00884999023932 UDI-DI Date1 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMA from GUDID NumberBP060002 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA premarket submission BP060002 Active
  • FDA GUDID UDI-DI 00884999023932 listed 1 Jul 2016 Listed

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  • Withdrawn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
HIV1 nucleic acid IVD, control
Model / Ref / Catalog
6L18-80
Primary DI / UDI-DI
00884999023932
FDA product code
MZF
GMDN term
HIV1 nucleic acid IVD, control
Device class
Class II
Regulation number
866.3956
GUDID distribution status
In Commercial Distribution

Related devices

Category: HIV1 nucleic acid IVD, control

Cleared under the same submission (BP060002)

and 4 more cleared under BP060002

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)