Novocastra CK20-L-U

by Leica Biosystems Newcastle, Limited

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05055331333544 UDI-DI	Date28 Jul 2023Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Novocastra
Generic Name: Cytokeratin IVD, antibody
Model / Ref / Catalog: CK20-L-U, NCL-L-CK20-U

Primary DI / UDI-DI: 05055331333544
FDA Product Code: NJT
GMDN Term: Cytokeratin IVD, antibody

Device Class: Class I
Regulation Number: 864.1860
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Premarket Exempt
Lot / Batch Number
Expiration Date

Other properties (10)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Manufacturing Date: No