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SoftBiopsy SFT-1000

by Histologics, LLC

SoftBiopsy SFT-1000 is a Class I device made by Histologics, LLC, listed in FDA GUDID since 10 Nov 2019 (UDI-DI 00860275000316), registry data as of 8 Nov 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860275000316 UDI-DI Date10 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
SoftBiopsy
Generic name
Cervical cytology brush
Model / Ref / Catalog
SFT-1000
Primary DI / UDI-DI
00860275000316
FDA product code
HFB, GEE
GMDN term
Cervical cytology brush
Device class
Class I
Regulation number
884.4530, 878.4800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cervical cytology brush

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Other devices filed under Cervical cytology brush.

Other devices from Histologics, LLC

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)