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Vysis

FDA UDI

Class I (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
Vysis FDA UDI
Generic Name
Cancer/tumour-associated aneuploidy IVD, probe FDA UDI
Device Name
ProbeChek Negative Control 0% Trisomy 8/12 FDA UDI
Model / Reference
07J21-001 FDA UDI
Description
ProbeChek Negative Control 0% Trisomy 8/12 FDA UDI

Identifiers

Catalog Number
07J21-001 FDA UDI
Primary DI / UDI-DI
00884999027039 FDA UDI
510(k) Number
K953591 FDA UDI
K962873 FDA UDI
FDA Product Code
KIR FDA UDI
OVQ FDA UDI
OYU FDA UDI
GMDN Term
Cancer/tumour-associated aneuploidy IVD, probe FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.2280 FDA UDI
866.6040 FDA UDI
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: Cancer/tumour-associated aneuploidy IVD, probe

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

Similar devices

Also classified as Cancer/tumour-associated aneuploidy IVD, probe.

Cleared under the same submission

K953591 also covers:

K962873 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 01a34f50-cab0-4ec6-94fd-e7461b4e2f35 37 fields · synced Jun 7, 2026