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Vysis

FDA UDI

Class I (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
Vysis FDA UDI
Generic Name
Nucleic acid hybridization detection IVD, probe FDA UDI
Device Name
Vysis ToTelVysion MultiColor FISH Probe FDA UDI
Model / Reference
05J05-001 FDA UDI
Description
Vysis ToTelVysion MultiColor FISH Probe FDA UDI

Identifiers

Catalog Number
05J05-001 FDA UDI
Primary DI / UDI-DI
00884999010703 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Nucleic acid hybridization detection IVD, probe FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Nucleic acid hybridization detection IVD, probe

Vysis by Abbott Molecular — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid hybridization detection IVD, probe.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Molecular

Sources (1)

  • FDA UDI 51863cfe-e840-4c26-bd92-a0036ee99a18 36 fields · synced Jun 1, 2026