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Vysis

FDA UDI

Class II (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
Vysis FDA UDI
Generic Name
Multiple congenital aneuploidy screening IVD, probe FDA UDI
Device Name
AneuVysion DNA Probe Kit FDA UDI
Model / Reference
05J38-030 FDA UDI
Description
AneuVysion DNA Probe Kit FDA UDI

Identifiers

Catalog Number
05J38-030 FDA UDI
Primary DI / UDI-DI
00884999011700 FDA UDI
510(k) Number
K010288 FDA UDI
FDA Product Code
OYU FDA UDI
GMDN Term
Multiple congenital aneuploidy screening IVD, probe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.4700 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple congenital aneuploidy screening IVD, probe

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

Similar devices

Also classified as Multiple congenital aneuploidy screening IVD, probe.

Cleared under the same submission

K010288 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Molecular

Sources (1)

  • FDA UDI bfda0a79-c3de-4d21-885d-a07eb20d4382 37 fields · synced May 31, 2026