PTEN DNP Probe ASR 06620353001

by Ventana Medical Systems

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	Number04015630970865 UDI-DI	Date3 Feb 2021Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: PTEN DNP Probe ASR
Generic Name: Assay development analyte-specific reagent IVD
Model / Ref / Catalog: 06620353001

Primary DI / UDI-DI: 04015630970865
FDA Product Code: MVU
GMDN Term: Assay development analyte-specific reagent IVD

Device Class: Class I
Regulation Number: 864.4020
GUDID distribution status: In Commercial Distribution

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Properties

Premarket Exempt
Lot / Batch Number
Expiration Date

Other properties (11)

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
Serial Number: No
Manufacturing Date: No