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SimpleScreen CRC 101216

by Exact Sciences Corporation

SimpleScreen CRC 101216 is a Class III device made by Exact Sciences Corporation, listed in FDA GUDID since 22 Oct 2026 (UDI-DI 00850057859362), registry data as of 2 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 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850057859362 UDI-DI Date22 Oct 2026ListedStatusListed 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  • Withdrawn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
SimpleScreen CRC
Generic name
Venous blood collection kit IVD
Model / reference
101216
Primary DI / UDI-DI
00850057859362
FDA product code
PHP
GMDN term
Venous blood collection kit IVD
Device class
Class III
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code PHP (System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection).

Other devices from Exact Sciences Corporation

See all devices from Exact Sciences Corporation →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)