Tinto Cytokeratin 16, RMab Prediluted, 7 ml

by Bio Sb, Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB502BSB28880 UDI-DI	Date1 Jun 2020Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Tinto Cytokeratin 16, RMab
Generic Name: Cytokeratin IVD, antibody
Model / Ref / Catalog: Prediluted, 7 ml, BSB 2888

Primary DI / UDI-DI: B502BSB28880
FDA Product Code: NJT
GMDN Term: Cytokeratin IVD, antibody

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

MRI Safety: MR Safe

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Properties

Premarket Exempt

Other properties (13)

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