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RealTime 06L83-008

by Abbott Molecular

RealTime 06L83-008 is a Class II device made by Abbott Molecular, listed under FDA premarket submission BP060002 and listed in FDA GUDID since 19 Jan 2019 (UDI-DI 00884999048065), 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 Number00884999048065 UDI-DI Date19 Jan 2019ListedStatusListed 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 00884999048065 listed 19 Jan 2019 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  • Withdrawn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
Laboratory instrument/analyser application software IVD
Model / Ref / Catalog
06L83-008
Primary DI / UDI-DI
00884999048065
FDA product code
MZF
GMDN term
Laboratory instrument/analyser application software IVD
Device class
Class II
Regulation number
866.3956
GUDID distribution status
In Commercial Distribution

Related devices

Category: Laboratory instrument/analyser application software IVD

Cleared under the same submission (BP060002)

and 4 more cleared under BP060002

Similar devices in this category

Other devices filed under Laboratory instrument/analyser application software IVD.

Other devices from Abbott Molecular

See all devices from Abbott Molecular →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
Other properties (12, all answered No)