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ThinPrep 2000 Processor

by Hologic 2 variants

ThinPrep 2000 Processor (70031-001) is a Class III device made by Hologic, approved under FDA PMA P950039 on 20 May 1996 and listed in FDA GUDID since 2 Sep 2014 (UDI-DI 15420045500839), 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 P950039

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 Number15420045500839 UDI-DI Date2 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP950039 Date20 May 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P950039 decided 20 May 1996 Active
  • FDA GUDID UDI-DI 15420045500839 listed 2 Sep 2014 Listed

Timeline

2 dated events

  1. Approved FDA PMA P950039
  2. Listed FDA GUDID 15420045500839

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Generic name
Microscope slide maker IVD
Model / Ref / Catalog
ThinPrep 2000 Processor, 70031-001
Primary DI / UDI-DI
15420045500839
PMA number
FDA product code
MKQ
GMDN term
Microscope slide maker IVD
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Microscope slide maker IVD

Cleared under the same submission (P950039)

and 8 more cleared under P950039

Similar devices

Other devices filed under FDA product code MKQ (Processor, cervical cytology slide, automated).

Other devices from Hologic

See all devices from Hologic →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)