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CG2 Cap Bds 100699

by Exact Sciences Corporation

CG2 Cap Bds 100699 is a Class III device made by Exact Sciences Corporation, approved under FDA PMA P230043 on 3 Oct 2024 and listed in FDA GUDID since 19 Feb 2025 (UDI-DI 00850057859003), active as of 22 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 22 Oct 2026

Documents

PMA P230043

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850057859003 UDI-DI Date19 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP230043 Date3 Oct 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P230043 decided 3 Oct 2024 Active
  • FDA GUDID UDI-DI 00850057859003 listed 19 Feb 2025 Listed

Timeline

2 dated events

  1. Approved FDA PMA P230043
  2. Listed FDA GUDID 00850057859003

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
CG2 Cap Bds
Generic name
Nucleic acid extraction/isolation kit IVD
Model / reference
100699
Primary DI / UDI-DI
00850057859003
PMA number
FDA product code
PHP
GMDN term
Nucleic acid extraction/isolation kit IVD
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Cleared under the same submission (P230043)

and 8 more cleared under P230043

Similar devices in this category

Other devices filed under Nucleic acid extraction/isolation kit IVD.

Other devices from Exact Sciences Corporation

See all devices from Exact Sciences Corporation →

Properties

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