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RealTime 06L87-02

by Abbott Molecular

RealTime 06L87-02 is a Class II device made by Abbott Molecular, approved under FDA PMA P120012 on 20 Jun 2013 (1 earlier submission), cleared under FDA 510(k) K080739 on 10 Jul 2008 and listed under FDA premarket submission BP060002 and in 1 more registry, active as of 23 Oct 2026.

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

PMA 510(k)

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

PMA P120012

+3 more

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884999037472 UDI-DI Date15 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPRL from GUDID NumberP120012 Date20 Jun 2013DecidedStatusActive
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK080739 Date10 Jul 2008DecidedStatusActive

Official records

Across registries

4 registries list this device

  • FDA PMA P120012 decided 20 Jun 2013 Active· +1 more in the status table
  • FDA 510(k) K080739 decided 10 Jul 2008 Active
  • FDA premarket submission BP060002 Active
  • FDA GUDID UDI-DI 00884999037472 listed 15 Dec 2017 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K080739
  2. Approved FDA PMA P100017
  3. Approved FDA PMA P120012
  4. Listed FDA GUDID 00884999037472

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA, FDA 510(k) Active

Specification

GUDID

Trade name
RealTime
Generic name
DNA anti-contamination enzyme reagent IVD
Model / Ref / Catalog
06L87-02
Primary DI / UDI-DI
00884999037472
PMA number
510(k) Number
FDA product code
MZP, LSL, OBF, MZF, MKZ
GMDN term
DNA anti-contamination enzyme reagent IVD
Device class
Class II
Regulation number
866.3170, 866.3390, 866.3956, 866.3120
GUDID distribution status
In Commercial Distribution

Related devices

Category: DNA anti-contamination enzyme reagent IVD

Cleared under the same submission (BP060002)

and 4 more cleared under BP060002

Cleared under the same submission (P100017)

Similar devices

Also classified as DNA anti-contamination enzyme reagent IVD.

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
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)