SysCheck KIT, SYSCHECK, IVD, CDRH, (CE)

SysCheck KIT, SYSCHECK, IVD, CDRH, (CE) (301078) is a Class I device made by Hologic, listed in FDA GUDID since 18 Sep 2017 (UDI-DI 15420045506862), registry data as of 23 Oct 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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number15420045506862 UDI-DI	Date18 Sep 2017Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 15420045506862

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: SysCheck
Generic name: Optical laboratory instrument performance standard calibrator/control IVD, reusable
Model / Ref / Catalog: KIT, SYSCHECK, IVD, CDRH, (CE), 301078

Primary DI / UDI-DI: 15420045506862
FDA product code: JJQ
GMDN term: Optical laboratory instrument performance standard calibrator/control IVD, reusable

Device class: Class I
Regulation number: 862.2300
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Premarket exempt
Lot / batch number
Expiration date

Other properties (11, all answered No)